MCMi News Archive

Archived medical countermeasure-related news from the FDA Office of Counterterrorism and Emerging Threats (OCET), Medical Countermeasures Initiative (MCMi) and federal partners. Also see our events archive.

Current news & events

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2021

• July 21, 2021: MCMi email - COVID-19 updates | Register now to learn about clinical trials involving high-consequence pathogens

• July 20, 2021: The Path Forward: A Federal Perspective on the COVID-19 Response - Testimony of Acting Commissioner Janet Woodcock, MD, before the Senate Committee on Health, Education, Labor, and Pensions

• July 19, 2021: An FDA Consumer Update, Learn More About COVID-19 Vaccines From the FDA, is now available in five additional languages: Spanish, Chinese, Korean, Tagalog, and Vietnamese. See the evidence for each COVID-19 vaccine and the reasoning behind the FDA’s Emergency Use Authorizations.  

• July 19, 2021: Global regulators envision paradigm shift toward inclusion of pregnant and breastfeeding women in clinical research for medicines and vaccines - "Even before COVID-19 shined a spotlight on this important issue, an escalating drumbeat of interest emerged from the FDA and other regulators to address information gaps that leave pregnant and breastfeeding women, along with their health care providers, to make important clinical decisions on the basis of scant data. We believe it is time for change so that pregnant women and their doctors will not be tasked with weighing the benefits and risks of treatment in the absence of information."  

• July 16, 2021: As Pfizer announced (PDF, 209 KB), the FDA has formally accepted the company’s Biologics License Application (BLA) requesting licensure (approval) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older and has granted the application priority review. Currently, the vaccine is authorized for emergency use to prevent COVID-19 in individuals ages 12 and older. The Prescription Drug User Fee (PDUFA) Goal Date of January 2022 reflects the PDUFA deadline for Priority Review and does not mean approval will not happen before that time. Quite to the contrary, the review of this BLA has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the PDUFA Goal Date. 

• July 15, 2021: FDA has created new product codes for certain medical devices authorized for emergency use under EUA. An applicable product code has been assigned to each authorized device category. The product codes are listed in the tables for each category of devices that have EUAs. The categories of devices are available on the Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices page. 

• July 15, 2021: Curative, Inc. requested that the FDA revoke the EUA for its test, the Curative SARS-Cov-2 Assay, effective July 15, 2021 because it will no longer be using that test. Curative, Inc. is offering different EUA-authorized SARS-CoV-2 tests for the testing offered at its laboratories. Accordingly, on July 15, 2021, the FDA revoked (PDF, 223 KB) EUA200132 for the Curative SARS-Cov-2 Assay, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). As of July 15, 2021, the Curative SARS-Cov-2 Assay is no longer authorized for emergency use by the FDA. 

• July 14, 2021: MCMI email - Hear from FDA leaders on Emergency Use Authorization | COVID-19 vaccine updates

• July 13, 2021: FDA announced revisions to the vaccine recipient (PDF, 248 KB) and vaccination provider (PDF, 485 KB) fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine to include information pertaining to an observed increased risk of Guillain-Barré Syndrome (GBS) following vaccination.

• July 13, 2021: FDA authorized the use (PDF, 213 KB), under the Emergency Use Authorization (EUA) for the Janssen COVID-19 Vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility. To date a total of five batches of Janssen drug substance that were manufactured at the Emergent facility have been authorized. The FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA has concluded that these batches are suitable for use. While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management.

• July 12, 2021: FDA reissues NIOSH-approved EUA to remove decontaminated or expired disposable respirators - FDA revised and reissued the NIOSH-approved EUA (PDF, 446 KB) so the scope of the products authorized under that EUA is in alignment with the actions taken on June 30, 2021, as well as FDA’s related announcements of April 9 and May 27, 2021. 

• July 9, 2021: FDA Authorizes First Quantitative Serology Test - FDA issued an EUA (PDF, 412 KB) to Ortho-Clinical Diagnostics, Inc., for the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative test. Quantitative serology tests that are traceable to a certified reference material may be helpful for ongoing medical research to study the immune response to SARS-CoV-2. 

• July 9, 2021: FDA has made publicly available a report on the use of additive manufacturing by non-traditional producers in support of the U.S. COVID-19 response. The study shows successes, challenges, and key lessons learned to build on and improve future crisis response. FDA is reviewing the report to assess gaps in the response and potential mitigations for future public health emergencies. See Advanced Manufacturing Public-private partnerships for more information about ongoing public-private partnerships to address challenges presented by advanced and continuous manufacturing technologies. 

• July 8, 2021: Joint CDC and FDA Statement on Vaccine Boosters 

• July 8, 2021: FDA hosted a Grand Rounds lecture about regulatory science research funded by the FDA: SARS-CoV-2 Host-Pathogen Interaction, Vaccines & Variants of Concern. This lecture discussed work from two FDA Medical Countermeasures Initiative (MCMi) projects analyzing coronavirus samples to help inform development of COVID-19 medical countermeasures, conducted by Public Health England and the University of Liverpool. A webcast recording is available. 

• July 7, 2021: Quidel is recalling its Lyra SARS-CoV-2 Assay (M120) due to a significant risk of false negative results for patients with relatively high amounts of SARS‐CoV‐2 virus. False negative results may lead to delayed diagnosis or treatment of SARS-CoV-2 which may cause patient harm including serious illness and death.

• July 7, 2021: MCMi email - FDA revokes EUAs for non-NIOSH-approved disposable respirators and decontamination systems | COVID-19 vaccine videos in more languages 

• June 30, 2021: FDA In Brief: FDA Revokes Emergency Use Authorizations for Certain Respirators and Decontamination Systems as Access to N95s Increases Nationwide
• June 30, 2021: MCMi email - FDA authorizes drug for treatment of COVID-19 | Use hand sanitizer in a well-ventilated area
• June 29, 2021: Myocarditis and pericarditis update - Acting FDA Commissioner, Janet Woodcock, M.D. and Director, FDA Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., discussed the suggested increased risks of myocarditis and pericarditis following COVID-19 vaccination with stakeholders on June 29, 2021. The recording is available on YouTube (47 minutes).
• June 25, 2021: FDA announced revisions to the patient and provider fact sheets for the Moderna and Pfizer-BioNTech COVID-19 vaccines regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination. For each vaccine, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) has been revised to include a warning about myocarditis and pericarditis and the Fact Sheet for Recipients and Caregivers has been revised to include information about myocarditis and pericarditis. 
• June 25, 2021: From HHS/ASPR and FDA - Pause in the Distribution of bamlanivimab/etesevimab
• June 24, 2021: FDA Authorizes Drug for Treatment of COVID-19 - FDA issued an emergency use authorization (EUA) for the drug Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is not authorized for use in outpatients with COVID-19.
• June 16, 2021: MCMi email - FDA takes steps to increase availability of COVID-19 vaccine
• June 15, 2021: FDA Approves StrataGraft for the Treatment of Adults with Thermal Burns - FDA approved StrataGraft for the treatment of adult patients with thermal burns containing intact dermal elements (remaining deep skin layers) for which surgical intervention is clinically indicated (also referred to as deep partial thickness burns). StrataGraft was developed in conjunction with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.
• June 11, 2021: FDA Takes Steps to Increase Availability of COVID-19 Vaccine - Following careful review and deliberation, FDA is taking important steps that will allow a critically needed supply of the Janssen (Johnson & Johnson) COVID-19 Vaccine to be made available. The agency announced today that it is authorizing for use (PDF, 410 KB), under the EUA for the Janssen COVID-19 vaccine, two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore.
• June 10, 2021: Based on data and information received from the manufacturer, FDA concurred (PDF, 26 KB) with the request to extend the shelf-life of Janssen COVID-19 Vaccine stored at 2-8^oC, from 3 months to 4.5 months. Health care providers may check the expiration date by lot number at the company’s website: https://vaxcheck.jnj/. Also see: Expiration Dating Extension
• June 10, 2021: Sodium Citrate Blood Specimen Collection Tube Conservation Strategies – Letter to Health Care and Laboratory Personnel - FDA added sodium citrate tubes used in blood specimen collection (product codes GIM and JKA) to the testing supplies and equipment – specimen collection category on the device shortage list. The device shortage list reflects the categories of devices the FDA has determined to be in shortage at this time, and the FDA will continue to update the lists as the COVID-19 public health emergency evolves.
• June 10, 2021: Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test - FDA Safety Communication
• June 9, 2021: MCMi email - FDA approves drug to treat smallpox | Strengthening the pharmaceutical supply chain | Your EUA questions answered

• June 8, 2021: A conversation with the FDA Chief Scientist: Learn about the Emergency Use Authorization (EUA) Process - new Health Equity Forum podcast

• June 8, 2021: Executive Order 14017 on America’s Supply Chains: HHS recommendations to help shore up the U.S. pharmaceutical supply chain - Keeping the U.S. drug supply chain secure, robust, and resilient is essential for the health and national security, and economic prosperity of the United States during emergencies like the COVID-19 pandemic and for the provision of day-to-day health care. On February 24, 2021, President Biden signed Executive Order 14017 to secure America’s critical supply chains. The Executive Order directed the Administration to launch an immediate 100-day review and strategy development process to identify and address vulnerabilities in the supply chains of four key product sectors, including pharmaceuticals. HHS led the development of a pharmaceutical supply chain report and its recommendations, which were published in a White House report (PDF, 6.1 MB) on June 8, 2021. 
• June 4, 2021: FDA approves drug to treat smallpox - FDA approved Tembexa (brincidofovir) to treat smallpox. Although the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that the virus that causes smallpox, the variola virus, could be used as a bioweapon. FDA approved Tembexa under the Animal Rule, which allows findings from adequate and well-controlled animal efficacy studies to serve as the basis of an approval when it is not feasible or ethical to conduct efficacy trials in humans.
• June 3, 2021: FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain - FDA finalized two guidance documents and made available two draft guidance documents to help ensure that prescription drugs are identified and traced properly as they move through the supply chain.
• June 3, 2021: FDA posted an update to the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to add new information about a potential impact on the performance of the Mesa Biotech Inc. Accula SARS-CoV-2 Test due to a genetic mutation at positions 28877-28878 (AG to TC) in patient samples.
• June 2, 2021: MCMi email - COVID-19 updates: new monoclonal antibody authorized, variant update, safety communication + more
• May 28, 2021: FDA issued a safety communication to warn the public to stop using the Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) because the FDA has serious concerns about the performance of the tests and believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared, or approved by the FDA. The FDA has identified this issue as a class I recall, which is the most serious type of recall. The FDA is aware that these unauthorized tests were distributed to pharmacies to be sold for at-home testing by consumers, as well as offered for sale directly to consumers.
• May 27, 2021: Update: FDA Recommends Transition from Use of Non-NIOSH-Approved and Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities - FDA is recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as using non-NIOSH-approved disposable respirators, including non-NIOSH-approved imported respirators such as KN95s.
• May 26, 2021: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19 - FDA issued an EUA (PDF, 388 KB) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death. This includes, for example, individuals who are 65 years of age and older or individuals who have certain medical conditions. Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2 and is designed to block the virus’ attachment and entry into human cells.
• May 26, 2021: MCMi email - Join the FDA Science Forum today | New MCMi report, including FDA COVID-19 response snapshot
• May 26, 2021: FDA published the MCMi Fiscal Year 2020 Program Update - FDA and our partners work every day to help facilitate development of and access to safe, effective medical countermeasures to counter emerging threats. Learn more about the steps we're taking to protect national health and security in this report. View the PDF (4.3 MB).
• May 25, 2021: FDA updated its guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, to include a new section that clarifies how the agency intends to prioritize review of EUA requests for the remainder of the COVID-19 public health emergency. As noted in the guidance, for the remainder of the current pandemic, the FDA may decline to review and process further EUA requests other than those for vaccines whose developers have already engaged with the agency as described in the guidance.
• May 25, 2021: FDA issued a report that describes some of the approaches used by the South Korean government to address COVID-19, particularly regarding development, authorization and use of diagnostic tests. Numerous sources around the world declared South Korea’s response strategy had successfully “flattened the curve” of COVID-19. As South Korea’s experience may be informative for future considerations, the FDA reviewed information, including reports in the press and information made publicly available by the South Korean government, about their COVID-19 response strategy.
• May 19, 2019: FDA receives HHS grant to expand CURE ID platform for COVID-19 treatments - The grant will fund expansion of the CURE ID platform to allow automated data collection from electronic health records (EHR) worldwide and clinical disease registries for COVID-19 and other difficult-to-treat infectious diseases.
• May 19, 2021: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available
• May 19, 2021: FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to Evaluate Immunity or Protection From COVID-19, Including After Vaccination - FDA issued a safety communication informing the public that results from SARS-CoV-2 antibody tests should not be used to evaluate immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination. Also see: FDA Safety Communication - Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA Safety Communication
• May 19, 2021: MCMi email - COVID-19 updates from FDA | Register for the FDA Science Forum
• May 18, 2021: FDA In Brief: Science Forum Highlights Regulatory Science Advancements in Protecting and Promoting Public Health - This event will showcase the collaborative efforts of the more than 11,000 scientists at the FDA as well as invited nationally renowned scientists, including Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases. Key topic areas include medical countermeasures, novel technologies, and advanced manufacturing.
• May 17, 2021: FDA Voices: Advancing FDA’s Mission by Targeting Key Areas for Regulatory Science Investment and Innovation
• May 17, 2021: FDA Provides Guidance on Master Protocols for Evaluating Prevention, Treatment Options for COVID-19
• May 17, 2021: Statement on Leronlimab from FDA's Center for Drug Evaluation and Research (CDER) - The statement outlines FDA’s conclusion that the data currently available from recent clinical trials do not show leronlimab can effectively treat COVID-19.
• May 12, 2021: MCMi email - FDA authorizes Pfizer-BioNTech COVID-19 Vaccine for emergency use in adolescents
• May 11, 2021: An Update from Federal Officials on Efforts to Combat COVID-19 - Testimony from Dr. Peter Marks, Director of the FDA Center for Biologics Evaluation and Research, before the U.S. Senate Committee on Health, Education, Labor and Pensions
• May 10, 2021: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic - FDA expanded the EUA for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.
• May 10, 2021: FDA In Brief: FDA to Hold Meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC)  to Discuss Pediatric Use of COVID-19 Vaccines - FDA will hold a VRBPAC meeting on June 10, 2021 to provide a status update on our approach to Emergency Use Authorization (EUA) for COVID-19 vaccines intended for use in individuals 12 through 17 years of age. The committee will also discuss the data needed to support an EUA and a Biologics License Application (BLA) for a COVID-19 vaccine intended for use in children less than 12 years of age. The committee will not discuss any specific products.
• May 10, 2021: Hurricane Season: Be Prepared - National Hurricane Preparedness Week is May 9-15, 2021. It's important to safeguard your food, water, medicine and pets before, during and after any severe weather event.
• May 7, 2021: Important update about bamlanivimab/etesevimab with regard to the P.1 variant in the state of Illinois (from ASPR and FDA)
• May 5, 2021: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations
• May 5, 2021: MCMi email - Safely using hand sanitizer + more COVID-19 response updates from FDA
• April 30, 2021: FDA revoked (PDF) the EUA of the Battelle CCDS Critical Care Decontamination System which was authorized for use in decontaminating compatible N95 respirators for multiple-user reuse by healthcare personnel. FDA revoked the EUA in response to Battelle’s request for voluntary withdrawal of the authorization. In response to changing customer needs, as of March 31, 2021, Battelle has ceased all Battelle CCDS decontamination site operations and marketing activities. As a reminder, decontaminated respirators and respirators that have undergone bioburden reduction should be used only when there are insufficient supplies of new filtering facepiece respirators (FFRs) or any new respirators. On April 9, 2021, FDA issued a letter to healthcare providers recommending transitioning from use of decontaminated disposable respirators. Additional information about revoked EUAs is available on the FDA website (see: Emergency Use Authorization--Archived Information).
• April 28, 2021: FDA updated the EUA Authorized Serology Test Performance page. The FDA provided information on the expected predictive value of authorized serology tests that have submitted performance data with SARS-CoV-2 antibody prevalence assumptions ranging from 5% to 50%. These estimates may help health care providers interpret these antibody test results for their patients. Additionally, the updated web page clarifies the use of serology tests when assessing a patient’s adaptive immune response.
• April 28, 2021: MCMi email - COVID-19 vaccine updates from FDA
• April 23, 2021: FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review - Following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the FDA and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.
• April 21, 2021: FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines - As part of our regulatory processes for reviewing all manufacturing facilities, FDA recently completed an inspection of Emergent BioSolutions, a proposed manufacturing facility for the Johnson & Johnson COVID-19 Vaccine. As Johnson & Johnson announced last month, the FDA has not authorized this facility to manufacture or distribute any of Johnson & Johnson’s COVID-19 Vaccine or components and, to date, no COVID-19 vaccine manufactured at this plant has been distributed for use in the U.S. The FDA’s inspections are thorough, and these assessments review the quality of manufacturing procedures, including records, staff training, facility operations, drug production and testing and the systems in place to ensure product quality. During an inspection of Emergent BioSolutions that ended Tuesday, the FDA cited a number of observations concerning whether the facility’s processes met our requirements and standards. These observations are outlined in our inspection closeout report (PDF, 16 MB), also known as a “FDA Form 483.”
• April 21, 2021: MCMi email - COVID-19 vaccine FAQ updates | #VaccineReady toolkit | New streamlined Emergency Use Authorization approach for serial testing
• April 20, 2021: FDA Announces New Streamlined Approach to Add Pooled Serial Screening Claims to Certain Authorized Tests for Use in Serial Testing Programs
• April 16, 2021: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab - FDA revoked the EUA that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use. Therefore, the agency determined that the criteria for issuance of an authorization are no longer met and has revoked the EUA.
• April 14, 2021: FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19
• April 14, 2021: MCMi email - Ensuring the safety and quality of COVID-19 vaccines | Registration open for training: Achieving Data Quality & Integrity in Maximum Containment Laboratories
• April 13, 2021: Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine
• April 12, 2021: Vaccine Ready: Addressing COVID-19 Health Disparities among Racial and Ethnic Minority Communities - also see the #VaccineReady Social Media Toolkit with resources in English and Spanish
• April 6, 2021: FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System
• April 2, 2021: FDA In Brief: FDA Provides Update on COVID-19 Pandemic Recovery and Preparedness Plan Initiative
• April 1, 2021: FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number of Vaccine Doses Available
• March 31, 2021: FDA Continues to Advance Over-the-Counter and Other Screening Test Development - FDA authorized several tests for over-the-counter (OTC) use without a prescription when used for serial screening.
• March 2021: FDA's Center for Devices and Radiological Health (CDRH) reorganized the SARS-CoV-2 In Vitro Diagnostics EUAs content on FDA.gov to help make it easier to find specific categories of EUAs and related information. With this update, new web pages have been created for these EUA types: Molecular Diagnostic Tests for SARS-CoV-2; Antigen Diagnostic Tests for SARS-CoV-2; Serology and Other Adaptive Immune Response Tests for SARS-CoV-2; IVDs for Management of COVID-19 Patients
• March 31, 2021: MCMi email - Learn more about COVID-19 vaccines | Emergency Use Authorization (EUA) updates
• March 30, 2021: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests - FDA posted a new web page for clinical laboratory staff and health care providers about the impact of viral mutations on COVID-19 molecular, antigen, and serology tests. The FDA will update this page as significant new information becomes available.
• March 24, 2021: Consumer Update - Learn More About COVID-19 Vaccines
• March 24, 2021: From HHS/ASPR - Update on COVID-19 variants and impact on bamlanivimab distribution
• March 24, 2021: MCMi email - How you can help stop COVID-19
• March 23, 2021: Center for Drug Evaluation and Research Response to Coronavirus (COVID-19) Infographic
• March 19, 2021: FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19 Infection
• March 18, 2021: FDA authorizes revisions to fact sheets to address SARS-CoV-2 variants for monoclonal antibody products under emergency use authorization - FDA authorized revised fact sheets for health care providers to include additional information on susceptibility of SARS-CoV-2 variants to each of the monoclonal antibody (mAb) therapies that are available through an EUA for the treatment of COVID-19. FDA is providing this information to equip health care providers with the most current data so they can make informed decisions and provide appropriate care to patients with COVID-19. Health care providers should review the fact sheets for details regarding specific variants and potential resistance that may make the authorized mAb therapies less effective.
• March 18, 2021: FDA’s Ongoing Use of Inspectional Tools for Ensuring Access to Safe, Quality Food and Medical Products During the COVID-19 Pandemic
• March 17, 2021: MCMi email - Know your COVID-19 treatment options | New adverse event reporting dashboard
• March 16, 2021: FDA takes steps to streamline path for COVID-19 screening tools, provides information to help groups establishing testing programs including a new supplemental template (Word doc) for test developers seeking EUA of certain tests for screening with serial testing. Serial testing involves testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always show up with a single test. Also see the new fact sheet: Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs
• March 15, 2021: New COVID-19 EUA FAERS Public Dashboard - The dashboard provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biological products used under EUA during the COVID-19 public health emergency. After launching the FAERS Public Dashboard, click on the COVID-19 EUA link at the top of the home page to open the COVID-19 EUA FAERS Public Dashboard.
• March 11, 2021: Know Your Treatment Options for COVID-19 - Patients today have more treatment options in the battle against coronavirus disease. FDA has approved one drug treatment for COVID-19 and has authorized others for emergency use during this public health emergency. In addition, many more therapies are being tested in clinical trials to evaluate whether they are safe and effective in combating COVID-19.
• March 10, 2021: MCMi email - Why you should not use ivermectin to treat or prevent COVID-19 | Beware of misleading registration certificates | New COVID-19 tests authorized
• March 5, 2021: Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 - Some people are taking ivermectin, a drug often prescribed for animals, to try to prevent or treat COVID-19. FDA has not approved or authorized ivermectin for this use, and it can be dangerous for people.
• March 5, 2021: FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test, a next generation sequencing based (NGS) test to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2
• March 5, 2021: FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test, the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription.
• March 4, 2021: FDA Alerts Public about Improper Use of Thermal Imaging Devices; Warns Firms for Illegally Offering Thermal Imaging Systems for Sale
• March 3, 2021: Are There "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved?
• March 3, 2021: MCMi email - Third COVID-19 vaccine authorized for emergency use | New at-home COVID-19 test
• March 2, 2021: National Consumer Protection Week: FDA Is Vigilant in Protecting Consumers Against COVID-19 Vaccine Scams
• March 1, 2021: FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test - another antigen test where certain individuals can rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis
• February 27, 2021: MCMi news alert: FDA issues EUA for third COVID-19 vaccine
• February 27, 2021: FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine - FDA issued an EUA for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.
• February 25,2021: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine - Update provides alternative temperature for transportation and temporary storage for frozen vials before dilution
• February 24, 2021: MCMi email - COVID-19 updates: vaccine safety surveillance, policies to guide medical product developers addressing virus variants, Feb. 25 health equity webinar
• February 22, 2021: Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants - FDA issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19.
• February 19, 2021: FDA In Brief: FDA warns about limitations and accuracy of pulse oximeters
• February 18, 2021: USDA, FDA Underscore Current Epidemiologic and Scientific Information Indicating No Transmission of COVID-19 Through Food or Food Packaging 
• February 10, 2021: MCMi email - COVID-19 therapeutics resources | Update on variants | Vaccines advisory committee scheduled for Feb. 26
• February 9, 2021: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 - FDA issued an EUA for a new monoclonal antibody combination administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions.
• February 4, 2021: FDA alerts health care professionals and compounders of potential risks associated with the compounding of remdesivir drug products
• February 4, 2021: FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.’s COVID-19 Vaccine Candidate
• February 4, 2021: FDA In Brief: FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data
• February 4, 2021: FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants
• February 3, 2021: MCMi email - Q&A on COVID-19 vaccines | Radiation treatment approved

• January 28, 2021: FDA approved a treatment to increase survival in adults and pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS]). For more information about this treatment, please see the NPLATE (romiplostim) product label (PDF, 684 KB). For more information about ARS, please see: Radiological and Nuclear Emergency Preparedness Information from FDA.

• January 27, 2021: MCMi email - New collaboration to increase advanced manufacturing for medical countermeasures | Updates on respirator decontamination systems, new guidances, and more

• January 26, 2021: Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers

• January 15, 2021: Accelerating the Adoption of Advanced Manufacturing Technologies to Strengthen Our Public Health Infrastructure -  FDA is creating a new collaboration with the National Institute of Standards and Technology (NIST) through a memorandum of understanding (MOU). This MOU is intended to increase U.S. medical supply chain resilience and advanced domestic manufacturing of drugs, biological products and medical devices through adoption of 21st century manufacturing technologies. These include smart technologies, such as artificial intelligence and machine learning, and emerging manufacturing processes. The MOU signals alignment between senior leadership at both institutions in recognition of the importance of modernizing regulatory frameworks as well as industry practices to meet public health needs in the U.S.

• January 13, 2021: Pandemic Response, Pandemic Preparation - This report reflects highlights of the agency’s response, accomplishments and activities and describes a broad set of potential prospective actions that the agency could consider going forward.

• January 13, 2021: MCMi email - Moderna COVID-19 Vaccine FAQs | SARS-CoV-2 viral mutation alert for health care and laboratory staff 

• January 11, 2021: FDA conducts regulatory science research, which is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of certain FDA-regulated products. It also enables the FDA to understand and assess risk, prepare for and respond to public health emergencies and help ensure the safety of products used by patients. Today, FDA published the report, 2021: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) (PDF, 2.7 MB).

• January 8, 2021: FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff - FDA is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus’s genome assessed by that test. The SARS-CoV-2 virus can mutate over time, like all viruses, resulting in genetic variation in the population of circulating viral strains, as seen with the B.1.1.7 variant. The FDA is taking additional actions to ensure authorized tests remain accurate by working with test developers and conducting ongoing data analysis to evaluate all currently authorized molecular tests. The FDA believes the risk that these mutations will impact overall testing accuracy is low.

• January 8, 2021: This week, the FDA posted a new web page, Moderna COVID-19 Vaccine Frequently Asked Questions. Questions cover specifics, such as what data did the FDA review when deciding whether to authorize the vaccine for emergency use, how well the vaccine prevents COVID-19, and more.

• January 6, 2021: MCMi email - Risk of false results with the Curative SARS-CoV-2 test for COVID-19 | New hand sanitizer toolkit | 2020 at FDA

• January 5, 2020: Moderna COVID-19 Vaccine Frequently Asked Questions (new web page)

• January 5, 2021: FDA Publishes Report on Advancing Alternative Methods - Report focuses on FDA activities to improve predictivity of human and animal response to FDA-regulated products

• January 5, 2021: CDER’s Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Efforts - The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020, to aid response efforts and ease the economic impact of COVID-19. FDA has posted a new web page listing specific authorities to enhance FDA’s ability to identify, prevent, and mitigate drug shortages.

• January 4, 2021: FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines

2020

• December 30, 2020: MCMi email - COVID-19 vaccine EUA updates: new FAQs and fact sheet translations

• December 21, 2020: MCMi email - FDA authorizes 2nd COVID-19 vaccine | Vaccine information now available in multiple languages | FDA approves Ebola therapeutic

• December 21, 2020: FDA Approves Treatment for Ebola Virus - FDA approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. Ebanga blocks binding of the virus to the cell receptor, preventing its entry into the cell.

• December 18, 2020: FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine - FDA issued an EUA for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

• December 17, 2020: FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting - Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.

• December 17, 2020: Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions - Questions cover specifics, such as what data did the FDA use to make the decision to authorize the vaccine for emergency use, to more general questions, such as how does a vaccine go from emergency use authorization to licensure.

• December 17, 2020: Vaccine EUA Questions and Answers for Stakeholders - New web page, with answers to legal questions for stakeholders including industry; health care providers; pharmacists; and state, local, tribal, and territorial governments

• December 16, 2020: FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test - FDA issued a new EUA for the BinaxNOW COVID-19 Ag Card Home Test which is authorized for use by patients at home with a prescription. The BinaxNOW COVID-19 Ag Card Home Test is authorized for prescription use at home with self-collected nasal swab samples from individuals ages 15 years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. It is also authorized for use with adult-collected nasal swab samples from individuals ages four years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.

• December 16, 2020: MCMi email - FDA issues EUA for first COVID-19 vaccine | First over-the-counter fully at-home test authorized

• December 15, 2020: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 - FDA issued an EUA for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older.

• December 15, 2020: FDA Insight podcast: Advanced Manufacturing - Dr. Jeffrey C. Baker, Deputy Director of the FDA’s Office of Biotechnology Products in the Center for Drug Evaluation and Research, joins Dr. Shah for a discussion on how FDA’s efforts help innovation and implementation of Advanced Manufacturing technologies regarding food and drug safety. Includes a discussion of why advanced manufacturing is important to public health, emergency preparedness and response.

• December 11, 2020: FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine c- FDA issued the first Emergency Use Authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The EUA allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.

• December 11, 2020: FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

• December 10, 2020: FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate as Part of Agency’s Review of Safety and Effectiveness Data

• December 9, 2020: MCMi email - Watch vaccine advisory committee meetings live Dec. 10 and 17

• December 4, 2020: PrecisionFDA has launched the COVID-19 Precision Immunology App-a-thon. The agency encourages the scientific and analytics community to develop innovative applications to explore the relationship between personalized immune repertoires and COVID-19 disease variables and associated factors. The challenge is open now through January 29, 2021.

• December 4, 2020: FDA Authorizes First COVID-19 and Flu Combination Test for Use with Home-Collected Samples

• December 2, 2020: MCMi email - Emergency Use Authorization for vaccines explained | Additional COVID-19 treatments authorized

• November 30, 2020: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate - FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 17, 2020, to discuss the request for Emergency Use Authorization (EUA) for a COVID-19 vaccine from Moderna Inc.

• November 23, 2020: FDA Launches Portal for Submission of Orphan Drug Designation Requests

• November 21, 2020: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 - FDA issued an EUA for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions.

• November 20, 2020: FDA updated a web page, Vaccine Development – 101, to provide an overview of the vaccine development process, and in a new webpage, Emergency Use Authorization for Vaccines Explained, the FDA offers answers to questions about EUAs, in general, and more specifically, about EUA requests for a vaccine intended to prevent COVID-19. Also see the infographic: The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization (PDF, 723 KB)

• November 20, 2020: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate - December 10, 2020 meeting to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.

• November 18, 2020: MCMi email - COVID-19 response updates from FDA: First COVID-19 test for self-testing at home | A closer look at COVID-19 diagnostic testing

• November 17, 2020: FDA Authorizes First COVID-19 Test for Self-Testing at Home - FDA issued an EUA for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results

• November 17, 2020: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs - Statement reaffirming FDA’s commitment to transparency around the EUA process and updates on FDA's plan to provide more information about decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines.

• November 16, 2020: A Closer Look at COVID-19 Diagnostic Testing - This overview may be of interest to health care providers, test purchasers, and public health staff who want to know more about different types of tests. A printable PDF (240 KB) is also available.

• November 10, 2020: MCMi email - COVID-19 updates from FDA: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19

• November 9, 2020: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19 - FDA issued an EUA for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.

• November 9, 2020: FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development

• November 4, 2020: MCMi email - COVID-19 updates from FDA: What to know about at-home oxygen therapy | Essential medicines, medical countermeasures, critical inputs

• October 30, 2020: FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order -
  A recent executive order directed the agency, in consultation with federal partners, to identify a list of essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms. The list and additional information, including a docket for public comment, is available at: Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputs.

• October 28, 2020: MCMi email - COVID-19 updates: FDA approves first treatment for COVID-19

• October 22, 2020: FDA Approves First Treatment for COVID-19 - FDA approved (PDF, 401 KB) the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval.

  This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA, PDF, 423 KB) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for Veklury to authorize the drug’s use for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical trials assessing the safety and efficacy of Veklury in this pediatric patient population are ongoing. Read more in the press release, and FDA’s approval of Veklury (remdesivir) for the treatment of COVID-19—The Science of Safety and Effectiveness

• October 21, 2020: MCMi email - COVID-19 updates from FDA | First FDA-approved Ebola virus treatment | About advisory committees

• October 20, 2020: The FDA’s Vaccines and Related Biological Products Advisory Committee and its Role in Advising the Agency on COVID-19 Vaccines, by Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research - Also see the Consumer Update: Advisory Committees Give FDA Critical Advice and the Public a Voice, and the FDA Insight podcast: Advisory Committee on COVID-19 Vaccines

• October 15, 2020: FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators (FFRs) Manufactured in China - Under the June 6, 2020 version of this EUA, a respirator was authorized if it met any of three predetermined eligibility criteria. Effective immediately, the reissued EUA no longer includes the three eligibility criteria, meaning the FDA will no longer review requests nor add to the list of authorized respirators–known as Appendix A—of this EUA based on those criteria. The FDA recognizes there is still a shortage of FFRs, and to provide additional capacity as needed, the agency is continuing the emergency use authorization of respirator models that are already included in Appendix A of this reissued EUA.

• October 14, 2020: FDA Approves First Treatment for Ebola Virus - FDA approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients. Also see the label (PDF, 638 KB), and from HHS, HHS Secretary Azar Statement on First FDA Approval of Ebola Therapeutic

• October 14, 2020: MCMi email - COVID-19 updates from FDA | Antimicrobial resistance paper & public meeting

• October 7, 2020: FDA Issues Warning Letter to Battelle Memorial Institute, a Manufacturer of an Authorized Decontamination System Used on Respirators

• October 7, 2020: MCMi email - COVID-19 updates from FDA: New COVID-19 vaccines page and guidance | SARS-CoV-2 research | Emergency Use Authorization updates

• October 6, 2020: FDA In Brief: FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines -  FDA issued guidance with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an Emergency Use Authorization (EUA) for an investigational vaccine intended to prevent COVID-19.

• October 6, 2020: COVID-19 Vaccines - Through oversight and regulation, the FDA ensures vaccine quality, safety and effectiveness – helping to facilitate the timely development of COVID-19 vaccines. Learn more and bookmark our new web page at: www.fda.gov/covid19vaccines

• October 5, 2020: FDA awarded a new research contract to the Stanford University School of Medicine to perform an in-depth analysis of tissue samples to learn more about how SARS-CoV-2—the virus that causes COVID-19— affects different systems in the body, and identify immune correlates. This regulatory science project could potentially help inform development and evaluation of medical countermeasures for COVID-19.

• October 1, 2020: FDA revised its Emergency Use Authorization (EUA, PDF, 388 KB) to reflect changes in the distribution and allocation of the antiviral drug Veklury (remdesivir). More information about the revised EUA can be found here, from HHS.

• September 30, 2020: MCMi email - COVID-19 updates from FDA: First point-of-care antibody test for COVID-19 | New patient outreach toolkit

• September 29, 2020: A Closer Look at the FDA’s Center for Devices and Radiological Health’s Unprecedented Efforts in the COVID-19 Response

• September 23, 2020: Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19 - FDA issued an Emergency Use Authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19. The Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection. That EUA was reissued (PDF, 356 KB) to authorize the test for POC use using fingerstick blood samples. This authorization means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing.

• September 23, 2020: FDA posted a document summarizing updated evidence to support the emergency use of COVID-19 Convalescent Plasma (PDF, 380 KB). The agency will continue to review the circumstances and appropriateness of the authorization for emergency use. To make this information accessible to the public, the document posted on the web presents FDA’s review in relatively plain language.

• September 23, 2020: MCMi email - COVID-19 updates from FDA: Beware of fraudulent coronavirus tests, vaccines, and treatments

• September 16, 2020: MCMi email - FDA's oversight of COVID-19 vaccines | New global coronavirus research project | Performance data for COVID-19 diagnostics

• September 15, 2020: Coronavirus (COVID-19) Update: FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests

• September 14, 2020: FDA and global partners to analyze coronavirus samples - In collaboration with NIH/NIAID, FDA awarded a research contract to the University of Liverpool to help inform development of COVID-19 medical countermeasure

• September 11, 2020: The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health, by Stephen M. Hahn, MD, Commissioner of Food and Drugs and Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research

• September 9, 2020: MCMi email - COVID-19 updates from FDA: Multilingual resources for consumers | Convalescent plasma guidance update

• September 4, 2020: FDA COVID-19 Response At-A-Glance Summary (PDF, 502 KB, updated)

• September 2, 2020: MCMi email - Watch out for hand sanitizers packaged in food and drink containers | First rapid COVID-19 test where results can be read directly from testing card (PDF, 151 KB)

• August 2020: FDA posted to our website a catalog of regulatory science tools to help assess new medical devices. This catalog collates a variety of regulatory science tools that the FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) developed and plans to expand as new tools become available.

• August 28, 2020: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines

• August 28, 2020: FDA Broadens Emergency Use Authorization for Veklury (remdesivir) to Include All Hospitalized Patients for Treatment of COVID-19

• August 27, 2020: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers

• August 26, 2020: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card

• August 26, 2020: MCMi email - COVID-19 updates from FDA: Emergency Use Authorization for convalescent plasma | Is your hand sanitizer on FDA's list of products you should not use (PDF, 166 KB)

• August 19, 2020: MCMi email - COVID-19 updates from FDA: More hand sanitizers consumers should not use | Device shortages during the COVID-19 public health emergency (PDF, 140 KB)

• August 18, 2020: From the Health Affairs Blog, FDA leadership on:

  • The FDA Response To COVID-19 At Six Months: Regulatory Innovation In The Face Of A Pandemic

  • FDA Initiatives To Accelerate The Development Of COVID-19 Therapeutics

  • FDA Support For Expedited Access To COVID-19 Diagnostics

  • Ensuring The Safety And Effectiveness Of A COVID-19 Vaccine

• August 18, 2020: FDA Insight podcast: Health Fraud and COVID-19 + listen to more episodes

• August 15, 2020: FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect, Which Uses a New Method of Saliva Sample Processing - FDA issued an EUA to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection. SalivaDirect does not require any special type of swab or collection device; a saliva sample can be collected in any sterile container. This test is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past.

• August 12, 2020: MCMi email - COVID-19 updates from FDA: FDA Commissioner message to health care providers | Coronavirus Treatment Acceleration Program updates (PDF, 141 KB)

• August 10, 2020: The Critical Role of Health Care Professionals During the COVID-19 Pandemic - speech by FDA Commissioner Stephen M. Hahn to the American Medical Association, with video

• August 7, 2020: FDA issued a memo (PDF, 86 KB) to government public health and emergency response stakeholders extending for the second time the expiration dates of certain lots of doxycycline hyclate 100 mg capsules held in strategic stockpiles for anthrax emergency preparedness and response purposes. Also see: Expiration date extensions of certain lots of doxycycline hyclate

• August 5, 2020: MCMi email - COVID-19 updates from FDA: Investing in advanced manufacturing to support public health preparedness | Donate COVID-19 plasma (PDF, 196 KB)

• August 3, 2020: Investing in Advanced Manufacturing to Support Public Health Preparedness - The potential public health value of advanced manufacturing is even greater in the context of the ongoing COVID-19 pandemic, which has highlighted the strain on supply chains and the need for adaptive manufacturing systems to accelerate the production of medical countermeasures. The FDA has established a strong regulatory foundation to support the uptake of advanced manufacturing, and COVID-19 provides the unique impetus to spur further advancement of medical manufacturing. Also see: Advanced Manufacturing

• July 31, 2020: FDA Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection - FDA authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in the individual’s blood.

• July 29, 2020: Coronavirus (COVID-19) Update: FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools - FDA posted a new template (Word doc) for commercial developers to help them develop and submit emergency use authorization (EUA) requests for COVID-19 diagnostic tests that can be performed entirely at home or in other settings besides a lab, such as offices or schools, and that could be available without a prescription.

• July 29, 2020: MCMi email - Hand sanitizer safety alert | First test authorized to screen people without known or suspected COVID-19 infection (PDF, 142 KB)

• July 28, 2020: FDA Insight: Vaccines for COVID-19, Part 2 - Dr. Peter Marks returns to the FDA Insight podcast for a more comprehensive discussion on vaccines as they relate to COVID-19. Find out more about “herd immunity,” Operation Warp Speed, and vaccine distribution in this episode.

• July 27, 2020: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products - FDA urges consumers, health care professionals not to use certain products, citing serious adverse events and death

• July 24, 2020: FDA Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection - Authorization is also second to allow testing of pooled samples

• July 22, 2020: MCMi email - COVID-19 response updates from FDA | Protecting patients and consumers from fraud (PDF, 146 KB)

• July 21, 2020: FDA Insight: Vaccines for COVID-19, Part 1 - In Part 1 of FDA Insight’s vaccine series, Dr. Shah welcomes Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, to discuss the basics of COVID-19 vaccine development.

• July 21, 2020: FDA’s Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability - FDA has been proactive and supportive of test development by all comers — including laboratories, and large and small commercial manufacturers — to speed development and to quickly authorize tests that the science supports.

• July 20, 2020: FDA’s Continued Commitment to the Safety and Security of Our Laboratories - FDA carries out scientific activities and regulatory analyses at laboratories nationwide. These activities are essential to informing regulatory decision-making and policy development as well as to supporting the agency’s efforts to speed development of innovative, safe and effective medical products. A cornerstone of the FDA’s scientific work is to ensure that we operate our laboratories and workplaces in a safe and secure manner to protect personnel and the surrounding communities.

• July 20, 2020: FDA Protects Patients and Consumers from Fraud During COVID-19 - As of June 2020, the FDA has identified more than 700 fraudulent and unproven medical products related to COVID-19.

• July 18, 2020: Coronavirus (COVID-19) Update: FDA Issues First Emergency Authorization (EUA) for Sample Pooling in Diagnostic Testing - FDA reissued an EUA to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples.

• July 15, 2020: MCMi email - Behind the Scenes: How FDA is Working to Facilitate COVID-19 Treatments (PDF, 150 KB)

• July 14, 2020: FDA Insight Podcast: Clinical Trials and Treatments for COVID-19 - Dr. Patrizia Cavazzoni, the acting director of FDA’s Center for Drug Evaluation and Research, joins Dr. Shah for an in-depth discussion on clinical trials and treatments for COVID-19. A list of clinical trials are available at ClinicalTrials.gov.

• July 14, 2020: FDA Voices: An Update and Behind the Scenes: FDA’s Coronavirus Treatment Acceleration Program

• July 14, 2020: FDA updated the Coronavirus Treatment Acceleration Program (CTAP) web page and posted key materials to provide information about CTAP’s purpose, strategy and operations. Specifically, this update included posting a dashboard showing crucial statistics related to the development of potential COVID-19 therapeutics. Also see: Ensuring the Safety of Patients in Clinical Trials Studying Investigational New Drugs to Prevent or Treat COVID-19

• July 10, 2020: Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system

• July 8, 2020: MCMi email - Coronavirus response updates from FDA - hand sanitizer and Emergency Use authorization updates, and a new podcast on food safety (PDF, 158 KB)

• July 6, 2020: False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System - Letter to Clinical Laboratory Staff and Health Care Providers - FDA is alerting clinical laboratory staff and health care providers of an increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test. In one study, the manufacturer found approximately 3% of results were false positive results.

• July 6, 2020: Coronavirus (COVID-19) Update: FDA Issued Emergency Use Authorization for Point of Care Antigen Test - FDA issued an EUA for a COVID-19 antigen diagnostic test, the BD (Becton Dickinson) Veritor System for Rapid Detection of SARS-CoV-2. This is the second antigen test the FDA has authorized for the detection of SARS-CoV-2 antigens.

• July 2, 2020: Coronavirus (COVID-19) Update: FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol - FDA is warning consumers and health care professionals about hand sanitizer products containing methanol, or wood alcohol that is dangerous and not an acceptable active ingredient for hand sanitizer products. Also see: FDA Updates on Hand Sanitizers with Methanol

• July 2, 2020: Coronavirus (COVID-19) Update: FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season - The FDA has issued an EUA for another combination diagnostic that can test for flu and COVID-19 to prepare for this upcoming flu season.

• July 1, 2020: MCMi email - Coronavirus response updates from FDA - vaccine development, Emergency Use authorization updates, and a new podcast on testing (PDF, 140 KB)

• June 30, 2020: Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines - The FDA published a guidance document to facilitate the timely development of safe and effective vaccines to prevent COVID-19, giving recommendations for those developing COVID-19 vaccines for the ultimate purpose of licensure.

• June 30, 2020: COVID-19: Update on Progress Toward Safely Getting Back to Work and Back to School - Hearing before the Senate Committee on Health, Education, Labor and Pensions; FDA Commissioner Stephen M. Hahn, M.D., testified for the FDA.

• June 30, 2020: FDA Insight Podcast: All About COVID-19 Testing - Dr. Anand Shah, FDA’s Deputy Commissioner for Medical and Scientific Affairs, welcomes Toby Lowe, the Associate Director of the Office of In Vitro Diagnostics and Radiological Health, to discuss the basics of diagnostic tests for COVID-19.

• June 25, 2020: Partnering with the European Union and Global Regulators on COVID-19 - The FDA and the European Union, including the European Commission and its European Medicines Agency, are collaborating on many scientific and regulatory fronts as part of our COVID-19 response.

• June 25, 2020: From HHS - HHS Secretary Azar Statement on End of Eastern DRC Ebola Outbreak - On June 25, 2020, the Democratic Republic of the Congo (DRC) Ministry of Health officially announced the end of the Ebola outbreak in the eastern DRC that has been ongoing since August 2018.

• June 24, 2020: MCMi email - 3D Printing in FDAs Rapid Response to COVID-19 | Updates for health care providers and industry on testing, device shortages, and more (PDF, 150 KB)

• June 23, 2020: FDA Insight Podcast: Fighting COVID-19 at the FDA - In this first episode of a new podcast series, FDA Commissioner Dr. Stephen Hahn, and FDA Deputy Commissioner for Medical and Scientific Affairs Dr. Anand Shah discuss FDA's COVID-19 efforts, including the drug development process for a COVID-19 treatment.

• June 23, 2020: FDA is partnering with the Critical Path Institute (C-Path) and the National Institutes of Health’s National Center for Advancing Translational Sciences (NCATS) on the CURE Drug Repurposing Collaboratory (CDRC). CDRC is a forum for the exchange of clinical practice data to inform potential new uses of existing drugs for areas of high unmet medical need, advancing research in these areas. CDRC will focus on capturing relevant real-world clinical outcome data through the FDA-NCATS CURE ID platform. In a pilot project focused on COVID-19, CDRC will use data collected via the CURE ID platform to aggregate global clinician treatment experiences to identify existing drugs that demonstrate possible treatment approaches warranting further study.

• June 23, 2020: FDA Maintains the Pace of Meeting Its Goals on Applications for Medical Products During the Pandemic - FDA is currently on target to meet our user fee goals for drugs this year. We have reviewed and taken timely action on at least 90% of brand, generic, and biosimilar drug applications even during the pandemic.

• June 23, 2020: Consumer Update: Getting Smarter about Food Safety: The Pandemic and Lessons Learned

• June 19, 2020: FDA updated the guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency, to facilitate notification regarding device manufacturing interruptions or discontinuance. See for more info: Medical Device Supply Chain Notifications During the COVID-19 Public Health Emergency

• June 19, 2020: FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem, due to the potential presence of methanol (wood alcohol), a substance that can be toxic when absorbed through the skin or ingested

• June 19, 2020: Certain COVID-19 Serology/Antibody Tests Should Not Be Used - Letter to Clinical Laboratory Staff and Health Care Providers

• June 19, 2020: 3D Printing in FDA’s Rapid Response to COVID-19 - FDA published a new web page, with updates on activities performed under the FDA, NIH, and VA Memorandum of Understanding (MOU) in collaboration with America Makes, signed in March 2020.

• June 18, 2020: FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts - FDA is announcing its participation in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics. The Diagnostics Evidence Accelerator is organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research.

• June 17, 2020: Coronavirus (COVID-19) Update: FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk - Today’s warning letters are the first set of letters the agency has issued for marketing adulterated or misbranded COVID-19 test kits.

• June 17, 2020: MCMi email - COVID-19 Emergency Use Authorization updates on drug products and tests (PDF, 140 KB)

• June 16, 2020: Coronavirus (COVID-19) Update: Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling - Diagnostic tests are an important tool in anticipating and meeting the continuing and evolving public health needs as we combat COVID-19. Today, the FDA took a meaningful step forward in getting more tests to more Americans more quickly and making that process even easier for developers by posting template updates regarding the validation of molecular diagnostic tests for developers that intend their assay to be used for pooling patient samples or for screening asymptomatic individuals not suspected of having COVID-19.

• June 15, 2020: Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine - On June 15, 2020, based on FDA’s continued review of the scientific evidence available for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) to treat COVID-19, FDA has determined that the statutory criteria for EUA as outlined in Section 564(c)(2) of the Food, Drug, and Cosmetic Act are no longer met.  Specifically, FDA has determined that CQ and HCQ are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use. This warrants revocation (PDF, 570 KB) of the EUA for HCQ and CQ for the treatment of COVID-19. Also see: Frequently Asked Questions on the Revocation of the EUA for HCQ and CQ

• June 11, 2020: Coronavirus (COVID-19) Update: FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19 - FDA issued (PDF, 128 KB) an Emergency Use Authorization (EUA) to Illumina, Inc. for the first COVID-19 diagnostic test utilizing next generation sequence technology. The FDA authorized the Illumina COVIDSeq Test for the qualitative detection of SARS-CoV-2 RNA from respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider. Using next generation sequencing means that the test can generate information about the genomic sequence of the virus present in a sample, which can be also used for research purposes.

• June 11, 2020: FDA Voices - Rare Disease Therapy Development and Access Remain Top FDA Priorities During COVID-19

• June 10, 2020: From HHS - BARDA, Chembio Diagnostics Partnership Results in FDA-Cleared Diagnostic Test for Zika - test becomes 55th FDA approval supported by BARDA, further improving U.S. emergency preparedness and response capability

• June 10, 2020: MCMi email - An introduction to COVID-19 tests | Emergency Use Authorization updates on ventilators, respirator decontamination, antibody tests | Testing supply substitution strategies (PDF, 144 KB)

• June 7, 2020: Coronavirus (COVID-19) Update: FDA Reissues Emergency Use Authorizations Revising Which Types of Respirators Can Be Decontaminated for Reuse - In response to public health and safety concerns about the appropriateness of decontaminating certain respirators, the agency is reissuing certain emergency use authorizations (EUAs) to specify which respirators are appropriate for decontamination. Based on the FDA’s increased understanding of the performance and design of these respirators, the FDA has decided that certain respirators should not be decontaminated for reuse by health care personnel.

• June 4, 2020: Coronavirus (COVID-19) Update: FDA Publicly Shares Antibody Test Performance Data From Kits as Part of Validation Study - FDA publicly posted test performance data from four more antibody, or serology, test kits on open.fda.gov from its independent performance validation study effort with the National Institutes of Health’s (NIH) National Cancer Institute (NCI). These results are among the first to come from a collaborative effort by the FDA, NIH, Centers for Disease Control and Prevention (CDC) and Biomedical Advanced Research and Development Authority (BARDA). Additional performance data will be made available as the FDA reviews and determines if any further actions are appropriate for those test kits prior to publication.

• June, 3, 2020: MCMi email - Understanding terminology of potential COVID-19 medical countermeasures | COVID MyStudies App | Reference panel for COVID-19 test developers (PDF, 273 KB)

• June 1, 2020: Coronavirus (COVID-19) Update: FDA Takes Action to Protect Public Health; Increase Supply of Alcohol-Based Hand Sanitizer - FDA has taken additional action to help ensure widespread access to hand sanitizers during the COVID-19 public health emergency.

• June 1, 2020: Remarks by Commissioner Stephen Hahn, M.D. — The COVID-19 Pandemic — Finding Solutions, Applying Lessons Learned

• May 27, 2020: MCMi email - Coronavirus antibody test transparency | Emergency Use Authorization updates + more (PDF, 129 KB)

• May 26, 2020: FDA Approves Only Drug in U.S. to Treat Severe Malaria

• May 21, 2020: New resource from HHS - ASPR’s Portfolio of COVID-19 Medical Countermeasures under Investigation

• May 21, 2020: Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests - FDA posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA. FDA expects that the tests on the removal list will not be marketed or distributed. Antibody tests offered by commercial manufacturers as outlined under the policy, which was issued on March 16 and updated on May 4, continue to be located on the notification list pending review of their EUA request.

• May 20, 2020: MCMi email - Coronavirus testing basics | Supply chain update | First standalone at-home sample collection kit authorized (PDF, 141 KB)

• May 19, 2020: USDA, FDA Strengthen U.S. Food Supply Chain Protections

• May 19, 2020: FDA Collaborations Promote Rigorous Analyses of Real-World Data to Inform Pandemic Response

• May 18, 2020: Coronavirus Testing Basics - You’ve probably heard a lot about coronavirus testing recently. If you think you have coronavirus disease 2019 (COVID-19) and need a test, contact your health care provider immediately. The FDA has been working around the clock to increase the availability of critical medical products, including tests for the coronavirus, to fight the COVID-19 pandemic. Learn more about the different types of tests and the steps involved

• May 16, 2020: Coronavirus (COVID-19) Update: FDA Authorizes First Standalone At-Home Sample Collection Kit That Can Be Used With Certain Authorized Tests

• May 15, 2020: New page for industry - Contacts for Medical Devices During the COVID-19 Pandemic

• May 14, 2020: HHS/ASPR is establishing the National Advisory Committee on Children and Disasters (NACCD). The Advisory Committee will provide advice and consultation to the HHS Secretary on pediatric medical disaster planning, preparedness, response, and recovery with respect to the medical and public health needs of children in relation to disasters. Applications will be accepted May 27 - June 27, 2020.

• May 13, 2020: MCMi email - New Emergency Use Authorization templates and firsts | Bilingual social media toolkit | Masks: working with FDA (PDF, 160 KB)

• May 11, 2020: Coronavirus (COVID-19) Update: FDA Takes New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19 - These guidance documents aim to make the process for submitting applications to initiate studies for new drugs and biological products more efficient and outline recommendations for ways to design clinical trials to evaluate safety and effectiveness of these medical products for COVID-19. Also see: COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders

• May 9, 2020: Coronavirus (COVID-19) Update: FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Causes COVID-19 in Patients - FDA issued the first EUA for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic. These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs.

• May 8, 2020: Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens

• May 7, 2020: Coronavirus (COVID-19) Update: FDA Continues to Combat Fraudulent COVID-19 Medical Products

• May 6, 2020: MCMi email - FDA issues Emergency Use Authorization for potential COVID-19 treatment, updates antibody test policy (PDF, 146 KB)

• May 4, 2020: Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy - FDA announced important updates to our March 16, 2020 policy on commercial manufacturers’ serology—or antibody—tests for COVID-19. Under the revised policy, FDA expects commercial manufacturers to submit Emergency Use Authorization (EUA) requests, including their validation data, within 10 days of the updated policy publication date, or the date they notify FDA of their test validation, whichever is later. FDA has also provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers. Two new serology EUA templates are available as Appendix A (for test kit manufacturers) and Appendix B (for laboratories) of the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) (PDF, 372 KB).

• May 1, 2020: Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment - FDA issued an EUA (PDF, 365 KB) for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients. Also see: Emergency Use Authorization and Frequently Asked Questions on the Emergency Use Authorization for Remdesivir for Certain
  Hospitalized COVID‐19 Patients (PDF, 99 KB)

• April 30, 2020: Coronavirus (COVID-19) Update: FDA Includes Ventilator Developed by NASA in Ventilator Emergency Use Authorization

• April 30, 2020: Consumer Update: Helpful Questions and Answers about Coronavirus (COVID-19) and Your Pets

• April 29, 2020: Consumer Update: Tips on Good Nutrition and Using the Updated Nutrition Facts Label During the Coronavirus Pandemic

• April 29, 2020: MCMi email - Coronavirus response updates: FDA provides flexibility to food industry to meet consumer demand during COVID-19, Emergency Use Authorizations + more (PDF, 162 KB)

• April 27, 2020: FDA recently posted FAQs on the Emergency Use Authorization for Face Masks (Non-Surgical) and FAQs on Emergency Use Authorizations (EUAs) for Medical Devices During the COVID-19 Pandemic - For more FAQs, see: Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions

• April 27, 2020: Coronavirus (COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns - As a result of the FDA's significant flexibility, more than 1,500 additional manufacturers have registered with the agency to produce hand sanitizer. At the same time, the agency is addressing safety concerns related to products being sold that are not in line with the FDA’s policy and others being marketed with unproven claims.

• April 24, 2020: Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems - Also see the Drug Safety Communication, FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems, also available as a podcast

• April 22, 2020: MCMi email - FDA’s actions in response to coronavirus disease | Shopping for food during the COVID-19 pandemic | Coronavirus Treatment Acceleration Program (PDF, 186 KB)

• April 21, 2020: Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection - FDA authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the Emergency Use Authorization (EUA) (PDF, 131 KB) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.

• April 21, 2020: FDA Voices: FDA Provides Flexibility to the Food Industry to Support Food Supply Chain and Meet Consumer Demand During COVID-19

• April 20, 2020: FDA Voices: The Path Forward: Coronavirus Treatment Acceleration Program - Given the urgent nature of the pandemic, the FDA launched a new program called the Coronavirus Treatment Acceleration Program (CTAP) to move new treatments to patients as soon as possible, while at the same time finding out whether they are helpful or harmful. So far, 72 clinical trials of potential therapies for COVID-19 are underway with FDA oversight. Also see: Coronavirus Treatment Acceleration Program (CTAP)

• April 18, 2020: Coronavirus (COVID-19) Update: Serological Test Validation and Education Efforts - Further details about FDA's thinking on these tests and our approach to making accurate and reliable serology tests widely available, while also protecting Americans from tests marketed with false or unsubstantiated claims.

• April 17, 2020: Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19 - FDA continues effort to protect the public from fraudulent and potentially harmful products.

• April 17, 2020: NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options - Health agencies, including FDA, and leading pharmaceutical companies to join forces to accelerate pandemic response.

• April 16, 2020: Coronavirus (COVID-19) Update: FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies - FDA has launched a new webpage to guide recovered COVID-19 patients to local blood or plasma collection centers to discuss their eligibility and potentially schedule an appointment to donate. The webpage also provides information for those interested in participating in the expanded access protocol, conducting clinical trials or submitting eIND applications.

• April 16, 2020: Coronavirus (COVID-19) Update: FDA Continues User-Fee Related Reviews Through COVID-19 - Throughout this public health emergency, FDA has continued to execute our review activities while responding to the public health needs of the current COVID-19 pandemic.

• April 16, 2020: Shopping for Food During the COVID-19 Pandemic - Information for Consumers - As grocery shopping remains a necessity during this pandemic, many people have questions about how to shop safely. We want to reassure consumers that there is currently no evidence of human or animal food or food packaging being associated with transmission of the coronavirus that causes COVID-19. Also available as a printable PDF (288 KB)

• April 16, 2020: Coronavirus (COVID-19) Update: FDA, Gates Foundation, UnitedHealth Group, Quantigen, and U.S. Cotton Collaborate to Address Testing Supply Needs - FDA announced a further expansion of COVID-19 testing options through the recognition that spun synthetic swabs – with a design similar to Q-tips – could be used to test patients by collecting a sample from the front of the nose.

• April 15, 2020: MCMi email - FDA’s actions in response to coronavirus disease | How you can make a difference (PDF, 142 KB)

• April 14, 2020: How You Can Make a Difference During the Coronavirus Pandemic - The COVID-19 pandemic has created challenges in our everyday lives. As we each do our part to help slow the spread of coronavirus disease, we look to the helpers all around us and wonder if we, too, could do more. Here are some ways you and your family can help.

• April 12, 2020: Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Decontaminate Millions of N95 Respirators - FDA issued an emergency use authorization (EUA) that has the potential to decontaminate approximately 4 million N95 or N95-equivalent respirators per day in the U.S. for reuse by health care workers in hospital settings. 

• April 10, 2020: Coronavirus (COVID-19) Update: FDA Issues Second Emergency Use Authorization to Decontaminate N95 Respirators - FDA  issued the second emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. This EUA will support decontamination of approximately 750,000 N95 respirators per day in the U.S.

• April 10, 2020: Coronavirus (COVID-19) Update: FDA Authorizes Blood Purification Device to Treat COVID-19 - FDA issued an EUA for a blood purification system to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

• April 10, 2020: How You Can Make a Difference During the Coronavirus Pandemic - The COVID-19 pandemic has created challenges in our everyday lives. As we each do our part to help slow the spread of coronavirus disease, we look to the helpers all around us and wonder if we, too, could do more. Here are some ways you and your family can help.

• April 9, 2020: FDA Combating COVID-19 with Therapeutics (PDF) - new quick reference, to be updated frequently

• April 8, 2020: MCMi email - FDA’s actions in response to coronavirus disease | FDA Commissioned Corps Officers on the Front Line (PDF, 120 KB)

• April 7, 2020: Coronavirus (COVID-19) Update: Serological Tests - Serological tests can play a critical role in the fight against COVID-19 by helping healthcare professionals to identify individuals who have overcome an infection in the past and have developed an immune response.

• April 7, 2020: Frequently Asked Questions on the Emergency Use Authorization (EUA) for Chloroquine Phosphate and Hydroxychloroquine Sulfate for Certain Hospitalized COVID-19 Patients (PDF, 265 KB)

• April 3, 2020: Coronavirus (COVID-19) Update: FDA Coordinates National Effort to Develop Blood-Related Therapies for COVID-19

• April 2, 2020: FDA Commissioned Corps Officers on the Front Line of COVID-19 Response - Almost 400 FDA Commissioned Corps officers deployed to aid in response to the coronavirus public health emergency

• April 2, 2020: Coronavirus (COVID-19) Update: FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic

• April 1, 2020: FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data Now Available - In response to the COVID-19 pandemic, the FDA—in collaboration with the Centers for Disease Control (CDC), the Biodefense and Emerging Infections Research Resources Repository (BEI Resources), the Institute for Genome Sciences at the University of Maryland and the National Center for Biotechnology Information (NCBI)—developed quality-controlled, reference sequence data for the SARS-CoV-2 reference strain for the United States.

• April 1, 2020: MCMi email - FDA’s actions in response to coronavirus disease | More Emergency Use Authorizations | 3D printing during COVID-19 (PDF, 95 KB)

• March 31, 2020: Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19 - This new program is using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus. Also see: Coronavirus Treatment Acceleration Program (CTAP)

• March 30, 2020: Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19 - FDA has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed.

• March 29, 2020: HHS/ASPR Strategic National Stockpile (SNS) Response to the COVID-19 Pandemic - As part of the ongoing response, the SNS is deploying personal protective equipment (PPE), including N95 respirators, surgical and face masks, face shields, gloves, and disposable gowns, to help prevent COVID-19 transmission in all 50 states, the nation’s four largest cities, and U.S. territories and ventilators to areas in need. The SNS is also working with its partners across the federal government to coordinate logistics operations in order to leverage all available resources to support the COVID-19 response.

• March 28, 2020: Coronavirus (COVID-19) Update: FDA takes further steps to help mitigate supply interruptions of food and medical products

• March 27, 2020: Coronavirus (COVID-19) Update: FDA takes action to help increase U.S. supply of ventilators and respirators for protection of health care workers, patients

• March 25, 2020: FDA Efforts to Connect Manufacturers and Health Care Entities: COVID-19 Response Public-Private Partnership - FDA entered a Memorandum of Understanding (MoU) with the Department of Veterans Affairs (VA) Innovation Ecosystem and the National Institutes of Health (NIH) 3D Print Exchange, to share data, and coordinate on open-source medical products for the COVID-19 response with other stakeholders such as America Makes.

• March 25, 2020: MCMi email - FDA’s actions in response to coronavirus disease | 16 diagnostic tests authorized for emergency use  (PDF, 95 KB)

• March 24, 2020: FDA Voices: FDA Offers Assurance About Food Safety and Supply for People and Animals During COVID-19

• March 24, 2020: Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers

• March 24, 2020: Investigational COVID-19 Convalescent Plasma - Emergency INDs - Also see: Frequently Asked Questions

• March 23, 2020: FDA Voices: FDA and EMA Collaborate to Facilitate SARS-CoV-2 Vaccine Development - Also see: Summary of FDA & EMA Global Regulators Meeting on Data Requirements Supporting First-in-Human Clinical Trials with SARS-CoV-2 Vaccines

• March 22, 2020: Coronavirus (COVID-19) Update: FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency

• March 22, 2020: Coronavirus (COVID-19) Update: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators

• March 21, 2020: Coronavirus (COVID-19) Update: FDA Issues first Emergency Use Authorization for Point of Care Diagnostic

• March 20, 2020: Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits

• March 20, 2020: Coronavirus (COVID-19) Update: FDA allows expanded use of devices to monitor patients’ vital signs remotely

• March 19, 2020: FDA advises patients on use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-19

• March 19, 2020: DHS Issues Guidance on the Essential Critical Infrastructure Workforce - The Department of Homeland Security (DHS)/Cybersecurity & Infrastructure Agency (CISA) issued new guidance to support state, local, and industry partners in identifying the critical infrastructure sectors and the essential workers needed to maintain the services and functions Americans depend on daily and need to be able to operate resiliently during the COVID-19 pandemic response. This includes essential workers in the food, health care, and public health sectors, including FDA-regulated industries.

• March 19, 2020: Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments

• March 19, 2020: Coronavirus (COVID-19) Update: Blood Donations

• March 18, 2020: MCMi email - FDAs actions in response to coronavirus disease at home and abroad | MCMi annual program update (PDF, 277 KB)

• March 17, 2020: Coronavirus (COVID-19) Update: FDA Issues Temporary Policy for FSMA Onsite Audit Requirements - The FDA took steps to help prevent disruptions in the food supply-chain by issuing a temporary policy for FDA Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements during the coronavirus (COVID-19) public health emergency.

• March 16, 2020: Coronavirus (COVID-19) Update: FDA Issues Diagnostic Emergency Use Authorization to Hologic and LabCorp - The FDA took two additional significant diagnostic actions during the coronavirus outbreak (COVID-19) by issuing Emergency Use Authorizations (EUAs) to: Hologic for its Panther Fusion SARS-COV-2 Assay, and Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test.

• March 16, 2020: Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics - The FDA updated a policy originally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S.

• March 16, 2020: From NIH - NIH Clinical Trial of Investigational Vaccine for COVID-19 Begins

• March 13, 2020: Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Thermo Fisher - The FDA took another significant diagnostic action during the coronavirus outbreak (COVID-19). The FDA issued the fourth COVID-19 diagnostic Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath COVID-19 Combo Kit.

• March 12, 2020: Coronavirus (COVID-19) Update: FDA gives flexibility to New York State Department of Health, FDA issues Emergency Use Authorization diagnostic - The two significant actions will expedite the availability of diagnostic tests.

• March 11, 2020: Surgical Mask and Gown Conservation Strategies - Letter to Healthcare Providers - The conservation strategies are intended to assist healthcare organizations as they determine operating procedures during the COVID-19 outbreak. The FDA is also collaborating with manufacturers of personal protective equipment (PPE) to help facilitate mitigation strategies related to the COVID-19 outbreak. Also see: FAQs on Shortages of Surgical Masks and Gowns

• March 11, 2020: MCMi email update -  FDA’s actions in response to coronavirus disease at home and abroad (PDF, 286 KB)

• March 10, 2020: New! Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions

• March 10, 2020: Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections -  After careful consideration, the FDA is postponing most foreign inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.

• March 9, 2020: Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19 - The FDA and the Federal Trade Commission issued warning letters to seven companies for selling fraudulent COVID-19 products.  These products are unapproved drugs that pose significant risks to patient health and violate federal law.  The FDA and FTC are taking this action as part of their response in protecting Americans during the global COVID-19 outbreak. Also see: Fraudulent Coronavirus Disease 2019 (COVID-19) Products

• March 6, 2020: HHS Solicits Proposals for Development of Medical Products for Novel Coronavirus - Also see Funding opportunities and challenge information below

• March 6, 2020: FDA's Center for Devices and Radiological Health (CDRH) has posted FAQs on Diagnostic Testing for SARS-CoV-2 Also see: Emergency Use Authorizations (Devices)

• March 4, 2020: HHS to Procure N95 Respirators to Support Healthcare Workers in COVID-19 Outbreaks - As part of the government-wide efforts to respond to the global outbreak of the 2019 novel coronavirus infection (COVID-19), the U.S. Department of Health and Human Services intends to purchase 500 million N95 respirators over the next 18 months for the Strategic National Stockpile (SNS).

• March 4, 2020: MCMi email update - FDA’s actions in response to coronavirus disease at home and abroad (PDF, 119 KB)

• March 2, 2020: Coronavirus (COVID-19) Update: FDA and CDC take action to increase access to respirators, including N95s, for health care personnel - In a joint effort, FDA and CDC took action (PDF, 129 KB) to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings. Today’s action allows certain National Institute for Occupational Safety and Health (NIOSH) approved respirators not currently regulated by the FDA to be used in a health care setting by health care personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system. Also see: Coronavirus Disease 2019 (COVID-19) EUA Information

• February 29, 2020: FDA granted an Emergency Use Authorization to two public health laboratories in New York for a diagnostic test to identify COVID-19. Additional technical information, including fact sheets

• February 29, 2020: Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics - As part of the U.S. Food and Drug Administration’s ongoing and aggressive commitment to address the coronavirus outbreak, the agency issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the U.S.

• February 29, 2020: FDA encourages development of diagnostic tests for Novel Coronavirus (COVID-19) and we issued an immediately in effect guidance with policy specific to this public health emergency.  The template for these EUA submissions is available. If you need additional information completing the template or wish to consider use an alternative specimen type, please contact the Division of Microbiology devices at (301) 348-1778 or email CDRH-EUA-Templates@fda.hhs.gov.

• February 27, 2020: Coronavirus (COVID-19) Supply Chain Update - FDA has been closely monitoring the supply chain with the expectation that the COVID-19 outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S. A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list. The manufacturer just notified us that this shortage is related to a site affected by coronavirus. The shortage is due to an issue with manufacturing an active pharmaceutical ingredient used in the drug. It is important to note that there are other alternatives that can be used by patients. We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage.

• February 24, 2020: Coronavirus Update: FDA steps to ensure quality of foreign products - FDA continues to take a multi-pronged approach to this public health emergency, including focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools, including enforcement tools to stop fraudulent activity.

• February 21, 2020: FDA is launching a new resource to assist external and agency researchers collecting historical information about FDA’s drug approvals. The Compilation of Center for Drug Evaluation and Research (CDER) New Molecular Entity (NME) Drug and New Biologic Approvals is a .CSV file available on the agency’s website that will provide researchers with curated data regarding drug products approved by CDER since 1985.

• February 19, 2020: MCMi email update - FDA’s actions in response to 2019 novel coronavirus at home and abroad (PDF, 120 KB)

• February 14, 2020: FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad - FDA's work is multifaceted, focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools as we oversee the safety and quality of FDA-regulated products for American patients and consumers.

• February 14, 2020: Important Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the 2019 Novel Coronavirus Outbreak - There have been no reported cases of transmission of COVID-19 via these products. Routine screening measures are already in place for evaluating clinical evidence of infection in HCT/P donors. [Note: this content was updated on July 2, 2020.]

• February 11, 2020: HHS issued a message (PDF, 162 KB) to state stakeholders holding antiviral drug products (Tamiflu and Relenza) about additional expiry dating extensions for properly held product. “…Based on FDA's review of scientific data, FDA has concluded for emergency responses that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Tamiflu 75 mg capsules held in strategic stockpiles to be used for a maximum of 15 years beyond their date of manufacture…[and] for certain lots of Relenza inhalation powder held in strategic stockpiles to be used for a maximum of 10 years beyond their date of manufacture…” HHS noted that states may contact their MCM Specialist or email preparedness@cdc.gov to confirm extended dates for antiviral drug inventories eligible for extension. To confirm extension dates, please provide the following information: drug name, NDC, strength, lot number and original manufacture date.

• February 10, 2020: From HHS - HHS Pioneers First Foundry for American Biotechnology - The U.S. Department of Health and Human Services launched the nation's first Foundry for American Biotechnology today to produce technological solutions that help the United States protect against and respond to health security threats, enhance daily medical care, and add to the U.S. bioeconomy.

• February 6, 2020: From CDC - Shipping of CDC 2019 Novel Coronavirus Diagnostic Test Kits Begins - A CDC-developed laboratory test kit to detect 2019 novel coronavirus (2019-nCoV) began shipping February 5, 2020, to select qualified U.S. and international laboratories. Distribution of the tests will help improve the global capacity to detect and respond to the 2019 novel coronavirus. The test kit has not been FDA cleared or approved, however distribution and use of the test kits follows FDA issuance of an Emergency Use Authorization on February 4, 2020. Also see from CDC: Information for Laboratories 2019-nCoV Requests for Diagnostic Panels and Virus

• February 5, 2020: MCMi email update - Novel coronavirus (2019-nCoV) updates from FDA (PDF, 125 KB)

• February 4, 2020: FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization (EUA) for the First 2019 Novel Coronavirus Diagnostic - FDA issued an EUA to enable broader emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; today’s authorization allows the use of the test at any CDC-qualified lab across the country. Additional technical information and fact sheets

• February 4, 2020: Important Information for Blood Establishments Regarding the Novel Coronavirus Outbreak - The potential for transmission of 2019-nCoV by blood and blood components is unknown at this time.  However, respiratory viruses, in general, are not known to be transmitted by blood transfusion, and there have been no reported cases of transfusion-transmitted coronavirus. Routine blood donor screening measures that are already in place should prevent individuals with clinical respiratory infections from donating blood. As a precaution, blood establishments may wish to consider whether to provide donor education, encourage self-deferral, and manage post-donation information about 2019-nCoV.

• January 31, 2020: FDA approved AUDENZ, (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) for active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine. AUDENZ is approved for use in persons 6 months of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine. This vaccine will be produced and distributed under contract to the U.S. Government as part of national pandemic preparedness initiatives. Also see, from HHS/ASPR: New Pandemic Influenza Vaccine Uses Next Generation Technology to Strengthen Health Security

• January 29, 2020: From HHS/ASPR - The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Multiyear Budget Report for fiscal years (FY) 2018–2022 has been posted. This report includes the multiyear budgets for the following Department of Health and Human Services (HHS) entities involved in MCM development and stockpiling: the National Institutes of Health (NIH), ASPR’s Biomedical Advanced Research and Development Authority (BARDA) and Strategic National Stockpile (SNS), and FDA.

• January 27, 2020: From the Wyss Institute - Human Body-on-Chip platform enables in vitro prediction of drug behaviors in humans - For information about FDA's support of this work, see: Human organ chips for radiation countermeasure development

• January 27, 2020: FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures - “We have a vital mission to protect and promote public health and the FDA is closely collaborating with our domestic and international public health partners to mitigate the impact of the novel coronavirus that emerged in Wuhan, China,” said FDA Commissioner Stephen M. Hahn, M.D. “We are actively leveraging the vast breadth of the FDA’s expertise and have begun employing the full range of our public health authorities to facilitate the development and availability of investigational medical products to help address this urgent public health situation.” Also see the new FDA web page: Novel coronavirus (2019-nCoV)

• January 22, 2020: MCMi email update - Funding deadline alert: Call for medical countermeasure regulatory science white papers (PDF, 72 KB) - Also see: Extramural Research

• January 21, 2020: FDA is requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Submit materials by February 20, 2020.

• January 10, 2020: Expiration date extension update - FDA is alerting civilian health care professionals and emergency responders of two additional DuoDote lots that are no longer useable and should be properly disposed of. Please refer to the table on this page for such updates: FDA alerts health care providers and emergency responders of expiration date extension updates for certain auto-injectors manufactured by Meridian Medical Technologies.

• January 8, 2020: MCMi email update - Register now for the training course Achieving Data Quality and Integrity in Maximum Containment Laboratories (PDF, 105 KB)

• January 7, 2020: From NIAID - The 2020 NIAID Omnibus Broad Agency Announcement No. HHS-NIH-NIAID-BAA2020-1 contains five distinct research areas, including Research Area 001 - Development of Radiation/Nuclear Medical Countermeasures (MCMs). The objective of this Research Area is to advance the development of candidate MCMs to reduce mortality and/or major morbidities associated with exposure to radiation from a radiological or nuclear incident. Proposals are due by 3:00 p.m. ET, April 9, 2020.

2019

• December 20, 2019: The FDA Office of Infectious Diseases is accepting proposals focused on updating susceptibility test interpretive criteria (breakpoints). Specifically, research proposals focused on evaluating microbiologic and pharmacokinetic data that could be utilized by standards development organizations and the FDA to update breakpoints will be prioritized. Proposals should be submitted to the FDA Broad Agency Announcement, priority area 2.4.4. Quad charts and white papers are due by February 28, 2020. Additional information about applying (Word doc, 25 KB)

• December 19, 2019: MCMi email update - Medical countermeasure news alert: First FDA-approved vaccine to prevent Ebola (PDF, 111 KB)

• December 19, 2019: First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response - FDA announced approval (PDF, 57 KB) of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older. Cases of EVD are very rare in the U.S., and those that have occurred have been the result of infections acquired by individuals in other countries who then traveled to the U.S., or health care workers who became ill after treating patients with EVD. Because of the public health importance of a vaccine to prevent EVD, FDA worked closely with the company and completed its evaluation of the safety and effectiveness of Ervebo in less than six months.

• December 18, 2019: MCMi email update - Save the dates for 2020 training courses | FDA authorizes marketing of MRSA diagnostic (PDF, 158 KB)

• December 9, 2019: From HHS - HHS Invests in Modernizing U.S. Manufacturing Capacity for Pandemic Influenza Vaccine - The U.S. Department of Health and Human Services (HHS) issued a six-year, $226 million contract to increase capacity to produce recombinant influenza vaccine in the United States. The contract is in accordance with the September 19, 2019, presidential executive order to enhance national security and the public health by modernizing influenza vaccines and technologies.

• December 6, 2019: FDA published a new web page, Availability of Regulatory Management Plans. The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, as amended by the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, furthered FDA’s mission of fostering the development and availability of medical countermeasures (MCMs) by codifying the development of Regulatory Management Plans (RMPs) for certain high-priority MCMs. Under section 565(f) of the Federal Food, Drug, and Cosmetic (FD&C) Act, sponsors or applicants of eligible MCMs can request an RMP, setting forth a formal process for obtaining scientific feedback and agency interactions regarding the development and regulatory review of eligible MCMs. This page provides information about RMPs for MCM sponsors or applicants.

• December 5, 2019: FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria - FDA authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections. The cobas vivoDx MRSA diagnostic test may allow health care professionals to evaluate patients for colonization with MRSA bacteria more quickly than traditional culture-based techniques when such testing is needed.

• December 5, 2019: FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases - FDA announced the global launch of CURE ID, an internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a website, a smartphone or other mobile device. The platform enables the crowdsourcing of medical information from health care providers to guide potentially life-saving interventions and facilitate the development of new drugs for neglected diseases. Also see: CURE ID App Lets Clinicians Report Novel Uses of Existing Drugs

• December 4, 2019: MCMi email update - Human organ chips for radiation countermeasure development | New winter events (PDF, 95 KB)

• November 26, 2019: FDA alerts health care providers and emergency responders of expiration date extensions of certain auto-injectors manufactured by Meridian Medical Technologies - This posting and FDA’s November 18, 2019, memorandum (PDF, 230 KB) provide expiration dating updates for health care professionals and emergency responders for certain lots of MMT AtroPen (atropine), CANA (diazepam), DuoDote, Morphine Sulfate, and Pralidoxime Chloride auto-injectors for use during nerve agent emergencies. This posting and memorandum replace FDA’s March 23, 2018, posting and all previous FDA web postings and memoranda notifying health care professionals and emergency responders about the expiration dating of such auto-injectors. Please refer to the table on this page for the new updates.

• November 25, 2019: Publication - FDA Zika virus reference panel for molecular-based diagnostic devices supports product testing for Emergency Use Authorization and 510(k) submissions - read the full publication in The Journal of Molecular Diagnostics

• November 21, 2019: Remarks by FDA Deputy Commissioner for Policy, Legislation, and International Affairs Anna Abram to the Biocom Celebration of Life Dinner - includes information about medical countermeasures and antimicrobial resistance, among other topics

• November 20, 2019: MCMi email update - New Ebola and Marburg virus research | Final guidance for developing smallpox treatments (PDF, 121 KB)

• November 15, 2019: FDA issues final guidance for development of smallpox treatments as part of critical preparedness efforts - FDA issued final guidance, Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention (PDF, 127 KB), which is designed to assist drug manufacturers designing studies to appropriately establish the safety and efficacy of drugs to treat or prevent smallpox infection.

• November 14, 2019: Balancing Patient Engagement and Awareness with Medical Device Cybersecurity (FDA Voices)

• November 14, 2019: FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance - FDA approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options. Also see: Antimicrobial Resistance Information from FDA

• November 6, 2019: MCMi email update - Ebola survivor study expanded | FDA clears 3rd Zika diagnostic test (PDF, 292 KB)

• October 30, 2019: Janet Woodcock, MD, Director of the FDA Center for Drug Evaluation and Research (CDER), testified before the House Committee on Energy and Commerce, Subcommittee on Health, on Safeguarding Pharmaceutical Supply Chains in a Global Economy. Dr. Woodcock's statement includes information about advanced manufacturing, including medical countermeasure manufacturing, and implications for national security.

• October 29, 2019: FDA issued a report, Drug Shortages: Root Causes and Potential Solutions, that attempts to identify root causes and offer recommendations for government and industry based on insights gleaned from stakeholders in the private and public sectors. These recommendations are intended to help prevent and mitigate future drug shortages. The report focuses on human drugs, but many of the same concerns apply to veterinary medicines used to treat service, companion, and food-producing animals. Also see: Drug Shortages

• October 28, 2019: FDA cleared the LIAISON XL Zika Capture IgM Assay II for the presumptive qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting the CDC Zika virus clinical and/or epidemiological criteria. Previously, the test had been authorized only for emergency use under FDA’s EUA authority.

• October 23, 2019: MCMi email update - Miss the FDA Science Forum or Scientific Computing Days? Recordings available | Learn about FDA's Cybercrime Investigations Unit (PDF, 182 KB)

• October 15, 2019: From HHS - BARDA and Johnson & Johnson Innovation – JLABS, working with Janssen Research & Development, LLC, announced the Invisible Shield QuickFire Challenge. Innovators are invited to submit ideas for potential solutions that repel and protect against airborne viruses while integrating seamlessly into everyday life. Submit applications by February 14, 2020.

• October 14, 2019: From HHS - The BARDA Division of Research Innovation and Ventures (DRIVe) seeks to partner with a third party entity (Venture Partner) that will address gaps in preparedness and areas within the continuum of response which require innovative and entrepreneurial approaches that would not be considered under traditional MCM development. Interested parties must respond to the RFI by November 18, 2019, 9:00 a.m. ET.

• October 11, 2019: From HHS/ASPR - The power of partnership: BARDA ushers in 50th FDA-approved product for health security

• October 10, 2019: FDA research update - Influenza candidate vaccine viruses improved by amino acid substitution in hemagglutinin - FDA scientists developed two candidate vaccine viruses (CVVs) that may be used as the starting material for production of inactivated influenza vaccines. These CVVs protected laboratory animals against a highly pathogenic strain of Influenza A (H7N9), a potentially pandemic virus. CVVs are influenza viruses that can be used commercially to produce vaccines to prevent influenza disease. Read more in the Journal of Virology: A Single Amino Acid Substitution at Residue 218 of Hemagglutinin Improves the Growth of Influenza A(H7N9) Candidate Vaccine Viruses

• October 10, 2019: MCMi email update - FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens (PDF, 110 KB)

• October 10, 2019: FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens - FDA allowed marketing (PDF, 255 KB) of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid). The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for Ebola virus disease (EVD). The test provides a rapid, presumptive diagnosis that must be confirmed.

• October 1, 2019: FDA cleared the Bacillus anthracis Detection Kit, a real-time polymerase chain reaction (PCR) test kit intended for the qualitative in vitro diagnostic (IVD) detection of target DNA sequences for B. anthracis, the bacteria that causes anthrax. This test is indicated for use in CLIA-certified high-complexity laboratories in response to a confirmed B. anthracis event only in accordance with the guidelines provided by public health authorities prior to or during a public health emergency.

• September 25, 2019: MCMi email update - FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox (PDF, 249 KB)

• September 24, 2019: From HHS - A Newly FDA-Licensed Vaccine for the Prevention of Smallpox and Monkeypox Marks a Major Milestone in Domestic and Global Health Security

• September 24, 2019: FDA announced the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. This is the only currently FDA-approved vaccine for the prevention of monkeypox disease. With this approval, FDA issued a material threat medical countermeasure (MCM) priority review voucher to Bavarian Nordic A/S.

• September 19, 2019: The President signed an Executive Order on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health. FDA's work to facilitate development of more effective cell lines that can be better scaled through advanced manufacturing technologies are one example of our commitment to fight flu. The flu vaccine remains one of the most effective and safest ways to protect you and others from the flu and serious flu-related complications. We strongly support these efforts to continue advancing work to modernize flu vaccine production.

• September 19, 2019: FDA has launched an updated version of the Food Defense Plan Builder (FDPB) to help companies meet the requirements of the Intentional Adulteration rule under the FDA Food Safety Modernization Act (FSMA). FDA will hold a webinar to provide stakeholders with a brief demonstration of the FDPB v. 2.0 and offer a question and answer session about the tool on October 10, 2019 at 1:00 p.m. ET.

• September 19, 2019: Human-Based Models to Study Space Radiation and Countermeasures: a TRISH Pre-release Webinar - Join the Translational Research Institute for Space Health (TRISH) for a webinar in preparation for a 2019 solicitation.

• September 17, 2019: FDA has published a new four-part videos series describing how physicians can submit Expanded Access requests for investigational drugs, including biologics, to the FDA, on behalf of a patient. Expanded Access is a potential pathway for a patient with a serious condition or disease to gain access to an investigational medical product outside of the clinical trial setting when no comparable options exist. Video transcripts are also available.

• September 17, 2019: FDA announced two new innovation challenges on device sterilization. Submissions for both are due October 15, 2019.

  • FDA Innovation Challenge 1: Identify New Sterilization Methods and Technologies
    The goal of this challenge is to identify safe and effective sterilization methods or technologies for medical devices that do not rely on ethylene oxide.
  • FDA Innovation Challenge 2: Reduce Ethylene Oxide Emissions
    The goal of this challenge is to develop strategies or technologies to reduce emissions to as close to zero as possible from the ethylene oxide sterilization process.

• September 11, 2019: MCMi email update - FDA action makes blood product more accessible to U.S. military | View the FDA Science Forum webcast live today (PDF, 140 KB)

• September 6, 2019: From HHS - BARDA has issued RFPs in support of BARDA clinical trials, including a call for contract research organizations to plan and conduct clinical trials (respond by October 21, 2019); to establish a new statistical and data coordinating center (respond by October 7, 2019); and to support the establishment of a new biospecimen storage facility (respond by October 7, 2019).

• August 29, 2019: FDA Action Makes Blood Product More Accessible to Warfighters in Combat - A recent action by FDA will help the military treat severely injured warfighters suffering from traumatic bleeding on the battlefield. On August 15, 2019, FDA granted a variance request submitted by the Army Blood Program for the use of cold stored platelets in theater for the Department of Defense (DoD). The issuance of this variance clears the way for platelets, a key blood component, to be refrigerated and stored for up to 14 days prior to treating bleeding patients when conventional platelet products are not available or their use is not practical. The approval of the variance request is another important action under the collaboration between FDA and DoD to expedite the development and availability of safe and effective medical products that are essential to the health of U.S. military service members. Also see: FDA/DoD Collaborations

• August 28, 2019: The National Institutes of Health (NIH) announced the publication of Reducing Administrative Burden for Researchers: Animal Care and Use in Research (PDF, 824 KB), a report by the NIH, the United States Department of Agriculture (USDA), and FDA. The report describes the recommendations of the 21st Century Cures Act, Section 2034(d), Working Group and decisions of the agencies.

• August 28, 2019: MCMi email update - Learn how predictive toxicology can support drug development, including medical countermeasures - September 18 workshop (PDF, 112 KB)

• August 27, 2019: Delivering Promising New Medicines Without Sacrificing Safety and Efficacy (FDA Voices) - All drugs approved under the agency’s expedited programs (e.g., Fast Track, Breakthrough Therapy) are held to the same approval standards as other FDA drug approvals.

• August 2019: A Cross-Disciplinary Training Program for the Advancement of Medical Countermeasures (Health Security, open access) - In September 2012, the FDA Office of Counterterrorism and Emerging Threats and the University of Texas Medical Branch at Galveston "entered into a collaborative educational partnership for the academic development of a robust training program for good laboratory practices in high-biocontainment environments. ... The program occurs annually and is expanding in 2019 to include a course addressing data quality and integrity in clinical trials involving the evaluation of MCMs for high-consequence pathogens. To date, 311 individuals have attended the course."

• August 21, 2019: From HHS/ASPR - HHS Funds an Additional Year of Ebola Vaccine Manufacturing - As part of the international response to the Ebola virus outbreak in the Democratic Republic of the Congo (DRC) and to meet domestic biodefense goals, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) will support manufacturing of an investigational Ebola vaccine, V920, from Merck & Co. Inc. of Kenilworth, New Jersey, known outside the U.S. and Canada as MSD.

• August 21, 2019: From HHS/ASPR - The Evolution of the Strategic National Stockpile (SNS) - For the last two decades, experts at the SNS have worked to stockpile lifesaving products and build partnerships so we are ready to respond when disaster strikes. As a result, today’s SNS has the capacity to get the right medicines, supplies and devices to the right people at the right time.

• August 20, 2019: FDA is requesting nominations for voting members to serve on the Blood Products Advisory Committee. Nominations received on or before October 21, 2019 will be given first consideration.

• August 19, 2019: FDA approves new antibiotic to treat community-acquired bacterial pneumonia - FDA today approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia. “For managing this serious disease, it is important for physicians and patients to have treatment options. This approval reinforces our ongoing commitment to address treatment of infectious diseases by facilitating the development of new antibiotics,” said Ed Cox, M.D., M.P.H., director of FDA’s Office of Antimicrobial Products.

• August 14, 2019: FDA approves new drug for treatment-resistant forms of tuberculosis that affects the lungs - FDA approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs. Pretomanid is the second drug to be approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, or LPAD pathway, established by Congress under the 21st Century Cures Act to advance development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need.

• August 14, 2019: MCMi email update - Register now for the FDA Science Forum | More September workshops (PDF, 122 KB)

• August 7, 2019: FDA is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Vaccines and Related Biological Products Advisory Committee (VRBPAC) for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the VRBPAC. Letters of interest/nomination materials are due by September 6, 2019.

• July 31, 2019: MCMi email update - Research centers: partner with FDA to apply for new advanced manufacturing innovation funding | Mustard gas countermeasure cleared (PDF, 103 KB

• July 31, 2019: The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announced that the University of Delaware, on behalf of NIIMBL, has entered into a Collaborative Research and Development Agreement (CRADA) with the FDA. Effective July 15, 2019, the FDA and NIIMBL will have the ability to collaborate in a pre-competitive environment to strengthen research, innovation, training, and collaboration in the biopharmaceutical manufacturing industry. For more information, see the new FDA web page Advanced Manufacturing

• July 22, 2019: From HHS - First medical product cleared in U.S. for use on certain injuries caused by sulfur mustard - “The FDA plays an important role in preparing our nation for a range of threats, including chemical, biological, radiological, and nuclear threats, providing guidance and support for the development of medical countermeasures that can be used safely, effectively and reliably during public health emergencies,” said Acting FDA Commissioner Ned Sharpless, MD. “The expanded indication for this first-of-its-kind wound contact dressing to include management of certain injuries caused by sulfur mustard vapor exposure demonstrates our commitment to working closely with our federal partners, including BARDA, to expedite the availability of medical countermeasures essential for managing responses to chemical weapons attacks in both civilian and battlefield settings.”

• July 17, 2019: FDA cleared the ADVIA Centaur Zika test. This is the second Zika diagnostic test FDA has allowed to be marketed in the U.S. for detecting Zika virus IgM antibodies. Previously, the test had been authorized only for emergency use under FDA’s EUA authority. FDA revoked the EUA for the ADVIA Centaur Zika test, initially issued on September 18, 2017.

• July 17, 2019: From HHS/ASPR: Project BioShield Evolution: Fifteen Years of Bridging the ‘Valley of Death’ in the Medical Countermeasures Pipeline

• July 17, 2019: FDA approves new treatment for complicated urinary tract and complicated intra-abdominal infections - FDA has approved Recarbrio (imipenem, cilastatin and relebactam), an antibacterial drug product to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection.

• July 17, 2019: MCMi email update - How FDA uses science to speed medical device innovation (PDF, 141 KB)

• July 15, 2019: From HHS - ASPR Next Innovation Day - ASPR Next is a new program to spur innovation in the development of new technologies and products that can be used to provide lifesaving care in austere circumstances. To kick off this initiative, ASPR is bringing together partners to discuss ways to develop cutting-edge technologies to save lives when disaster strikes. ASPR is looking for partners to us address issues in nine areas of interest to disaster response stakeholders, including medical countermeasure dispensing.  ASPR Next Innovation Day will be held on August 7-8, 2019 in Washington, DC and online.

• July 11, 2019: FDA Voices - How the FDA Uses Science to Speed Medical Device Innovation - The Medical Device Development Tools (MDDT) program streamlines the medical device development and review process by advancing the development and use of scientifically validated and qualified methods, materials, and measurements for assessing how devices work. FDA has developed and qualified the first nonclinical assessment model tool as part of the MDDT program.

• July 11, 2019: FDA Voices - Ensuring Patient Safety and Drug Manufacturing Quality Through Partnership with European Union Regulators - The Mutual Recognition Agreement (MRA) with the European Union (EU), allows FDA to more effectively deploy our inspectional resources across the globe. After five years of close FDA-EU cooperation, FDA has completed capability assessments of 28 EU member states.

• June 28, 2019: Consumer update - Plan, Prepare and Protect Your Pet Before, During and After an Emergency - When it comes to planning for emergencies, pet owners should consider their pets too.

• June 26, 2019: MCMi email update - Translating new technologies into safe, effective medical countermeasures | New preparedness legislation (PDF, 92 KB)

• June 24, 2019: The President signed into law S.1379, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PDF, 320 KB), which reauthorizes and modifies programs related to public health emergency preparedness and response. Also see: MCM-Related Counterterrorism Legislation

• June 17, 2019: FDA poliovirus assay is faster and more versatile than current assays used in vaccine development and environmental surveillance - FDA scientists have developed a poliovirus assay that is faster and more versatile than those now used to monitor polio vaccine production, assess patient responses to polio vaccines during clinical trials, and do environmental surveillance of vaccine poliovirus. The assay is also the first to measure the amount of several different strains simultaneously in a mixture of polioviruses. 

• June 14, 2019: From CDC - Dengue and Zika Virus Diagnostic Testing for Patients with a Clinically Compatible Illness and Risk for Infection with Both Viruses - This report summarizes existing and new guidance on dengue and Zika virus diagnostic testing for patients with a clinically compatible illness who live in or recently traveled to an area where there is risk for infection with both viruses.

• June 12, 2019: From CDC - CDC Activates Emergency Operations Center for Ebola Outbreak in Eastern DRC - The U.S. Centers for Disease Control and Prevention (CDC) is announcing activation of its Emergency Operations Center (EOC) on Thursday, June 13, 2019, to support the inter-agency response to the current Ebola outbreak in eastern Democratic Republic of the Congo (DRC). The DRC outbreak is the second largest outbreak of Ebola ever recorded and the largest outbreak in DRC’s history.

• June 12, 2019: The FDA Office of the Chief Scientist, Office of Counterterrorism and Emerging Threats is hiring a Visual Information Specialist (GS-12). Apply by June 25, 2019.

• June 12, 2019: MCMi email update - Got pathogens? (PDF, 75 KB)

• June 12, 2019: FDA supports the development of next-generation sequencing (NGS)-based diagnostics to help healthcare providers identify and treat the right pathogen. To help build NGS infrastructure, our FDA-ARGOS database makes publicly available quality-controlled microbial reference genomes for diagnostic use. The FDA team is looking for unique, hard-to-source microbes like biothreat organisms, emerging pathogens, and AMR-related pathogens to help improve the database. We encourage the community to share microbe samples.

• June 6, 2019: From HHS - BARDA-supported Zika Virus Test Receives FDA Clearance; Ready for Clinical Laboratory Use - The first commercially available Zika virus diagnostic, a product BARDA supported through its advanced research and development program, received authorization for marketing from FDA on May 23, 2019. The test provides results from a blood sample in about four hours. Called the ZIKV Detect 2.0 IgM Capture ELISA, the test exemplifies the progress that is possible with public-private partnerships.

• June 3, 2019: FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia - FDA approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. The FDA initially approved Zerbaxa in 2014 to treat complicated intra-abdominal infections and for complicated urinary tract infections.

• May 29, 2019: From HHS - HHS Seeks to Expand its Network Innovation Accelerators into More States -  Funding is available from the U.S. Department of Health and Human Services for organizations to provide specific biotechnology innovators with the technical and entrepreneurial support needed to accelerate development of their products. Applications are due by 11:59 p.m. ET July 23, 2019.

• May 29, 2019: MCMi email update - FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies | Hurricane preparedness (PDF, 144 KB)

• May 23, 2019: FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies - FDA authorized marketing (PDF, 175 KB) of the ZIKV Detect 2.0 IgM Capture ELISA to detect Zika virus immunoglobulin (IgM) antibodies in human blood. FDA reviewed data for the ZIKV Detect 2.0 IgM Capture ELISA test through the De Novo premarket review pathway. Also see: Zika Virus Response Updates from FDA

• May 16, 2019: From NIH - Human antibody reveals hidden vulnerability in influenza virus - Discovery by NIAID-funded researchers could aid quest for universal flu vaccine.

• May 15, 2019: From NIH - Two NIAID funding opportunity announcements seek applications with a focus on improving the relevance of influenza mouse models to human health. Application due dates vary by year. For the current year, applications are due by 5:00 p.m. ET June 10, 2019.

• May 9, 2019:The White House released its Global Health Security Strategy (PDF, 416 KB). The Strategy defines the actions the Administration will take to prevent, detect, and respond to infectious disease threats, whether naturally occurring, accidental, or deliberate.

• May 8, 2019: Antimicrobial resistance RFI from HHS - BARDA plans to support the procurement of antibiotic(s), which will either be delivered to the ASPR/SNS or maintained as VMI, using Project BioShield (PBS) funds. PBS funds will also support the necessary late-stage development to complete the regulatory pathway for a biothreat indication for the antibiotic(s) being procured (if applicable) and/or efforts related to post-marketing commitments. Respond by June 21, 2019. Also see, from ASPR: Project BioShield: Enhancing Preparedness, Ensuring Treatment Options

• May 8, 2019: MCMi email update - Anthrax preparedness guidance for government public health and emergency response stakeholders  | New FDA website (PDF, 152 KB)

• May 1, 2019: First FDA-approved vaccine for the prevention of dengue disease in endemic regions - FDA announced the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.

• April 24, 2019: FDA published a final guidance for government public health and emergency response stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. This document provides guidance to government stakeholders on testing to extend the shelf life (i.e., expiration date) under the FD&C Act of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. (Federal Register notice) More on Expiration Dating Extension

• April 24, 2019: MCMi email update - Join the National Biodefense Science Board | Emergency Use Authorization updates (PDF, 127 KB)

• April 18, 2019: EUA amendment - In response to Siemens Healthcare Diagnostic Inc.’s request, FDA concurred (PDF, 137 KB) with the request to modify the ADVIA Centaur Zika test to include surfactant in the ADVIA Centaur Zika IgM assay reagent buffers and the related updates of the Instructions for Use (PDF, 2.8 MB). For more information, see Emergency Use Authorizations (Devices)

• April 18, 2019: From NIH - Radiation/Nuclear Medical Countermeasure Product Development Support - The NIAID Radiation/Nuclear Countermeasures Program (RNCP) supports extramural research to develop safe and effective radiation medical countermeasures and biodosimetry methods and/or devices for clinical use under emergency situations. The purpose of this contract is to advance the development of candidate medical countermeasures (MCMs), including biodosimetric approaches to determine radiation exposure. We anticipate that studies supported by this contract will advance candidate MCMs toward eventual FDA approval or licensure for acute radiation syndrome (ARS) or delayed effects of acute radiation exposure (DEARE). Respond by August 19, 2019.

• April 17, 2019: FDA Voices on Medical Products: FDA's Efforts to Advance the Development of Biologics - The FDA’s Center for Biologics Evaluation and Research (CBER) is working at the forefront of 21st Century medicine. Many of the products regulated by CBER are either living cells or tissues, or are made from them, such as stem cells and genetically engineered immune cells. The Center’s diverse regulatory portfolio of complex biological products includes blood components and derivatives, vaccines, allergenics, and cellular and gene therapies. It also includes certain devices, including in vitro diagnostic tests for screening the blood supply and devices for the manufacturing of blood and tissue products. Also see CBER's FY 2018 Report from the Director

• April 15, 2019: From CDC - 10 Years Later: The Lasting Impacts of the H1N1 Flu Pandemic Response - As with previous pandemics, the scientific community, including experts at CDC, took away learned lessons that influence how we prepare and monitor for future pandemics.

• April 10, 2019: MCMi email update -28 new medical countermeasures in 2018 (new report!) | April 17 Biodefense Summit (PDF, 175 KB)

• April 9, 2019: FDA Voices on Policy: FDA Protecting the Nation through Medical Countermeasures - FDA’s Medical Countermeasures Initiative (MCMi) furthers the development of medical countermeasures by establishing clear regulatory pathways and effective regulatory policies and mechanisms to facilitate timely access to available medical countermeasures. The initiative also advances medical countermeasure regulatory science to create the tools that support timely regulatory decision-making. As today’s new report on the FDA’s medical countermeasure-related activities and achievements in fiscal year (FY) 2018 underscores, these efforts are leading to results.

• April 9, 2019: New report: MCMi Fiscal Year 2018 Program Update - FDA and our partners work every day to help facilitate development of and access to safe, effective medical countermeasures to counter emerging threats. Learn more about the steps we're taking to protect national health and security in this report. View the PDF (4 MB).

• April 3, 2019: From NIH - NIH begins first-in-human trial of a universal influenza vaccine candidate - The first clinical trial of an innovative universal influenza vaccine candidate is examining the vaccine’s safety and tolerability as well as its ability to induce an immune response in healthy volunteers. Scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, developed the experimental vaccine, known as H1ssF_3928.

• April 3, 2019: From NIH - Funding Opportunities for Emerging Infectious Diseases Research Centers - The network will conduct clinical and field studies of endemic zoonotic and vector-borne diseases that have the greatest potential to become pandemic threats, develop reagents for the broader research community, and during an outbreak mount a rapid and effective research response. Applications are due by 5:00 p.m. ET June 28, 2019.

• April 1, 2019: From CDC - Keeping Work with Select Agents Safe, Secure - Update on the Federal Select Agent Program, which is jointly run by CDC and the USDA’s Animal and Plant Health Inspection Service (APHIS).

• April 1, 2019: From HHS - The National Biodefense Science Board will begin accepting applications for new members on April 15, 2019. Apply by June 15, 2019.

• March 29, 2019: FDA finalizes requirements to help foster access to safe and effective tests to detect anthrax-causing bacteria - FDA issued a final rule classifying in vitro diagnostic devices for the detection of Bacillus bacteria into class II (special controls) and continuing to require a premarket notification (510(k)) for these devices.

• March 27, 2019: Medical countermeasure monitoring and assessment update | Advancing new TBI treatments and blood pathogen reduction technologies (PDF, 109 KB)    

• March 26, 2019: From HHS - HHS is soliciting nominations of individuals who are interested in being considered for appointment to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. Nominations must be received no later than 5:00 p.m. ET on May 10, 2019.

• March 22, 2019: FDA In Brief: FDA takes new steps to advance natural history studies for accelerating novel treatments for rare diseases

• March 21, 2019: New MCM monitoring and assessment project - Examining the Ability to Conduct Influenza Antiviral Effectiveness Studies in Sentinel by Improving Confounding Control - New collaboration with Harvard to explore how the Sentinel System may inform study protocols for MCM safety and effectiveness and to provide a valuable baseline for comparison during a public health emergency. The objective of this methods activity is to determine whether there is evidence of residual confounding in the association between influenza antiviral(s) and influenza complications in observational studies.

• March 20, 2019: From NIH - NIAID is seeking proposals to carry out research in one of three areas: radiation countermeasures, therapeutics for antibiotic-resistant (AR) bacteria, and vaccine candidates for AR bacteria. Submit proposals by May 20, 2019.

• March 19, 2019: From HHS - BARDA is looking for research fellows to help advance innovations in clinical trial design for medical countermeasures for health security threats. Applications due May 31, 2019.

• March 14, 2019: From HHS - Combating and Containing the Ebola Outbreak - Ebola and other highly infectious diseases can cross borders.  In order to protect the American people from this deadly disease, we must fight the outbreak at its source.  As a critical part of the global response, the U.S. Department of Health and Human Services (HHS) is developing and deploying medical countermeasures, which may help save lives by protecting individuals in DRC from infection and may reduce the severity of disease.  Within HHS, the Office of the Assistant Secretary for Preparedness and Response (ASPR) plays a critical role in medical countermeasure development and use.

• March 13, 2019: MCMi email update - Medical countermeasure funding deadline | FDA's critical role in ensuring supply of influenza vaccine (PDF, 179 KB) - subscribe (select Emergency Preparedness and Response - FDA Medical Countermeasures Initiative (MCMi) News)

• March 12, 2019: FDA In Brief: FDA takes new step to help advance the development of novel treatments for traumatic brain injury with the qualification of a medical device development tool - FDA qualified the OsiriX CDE Software Module (PDF, 401 KB), from the TBI Endpoints Development Initiative. This is the third qualification of a medical device development tool (MDDT) by the FDA, and the first of a biomarker test tool type. A biomarker test is a lab test or instrument used to detect or measure an indicator of biologic processes or pharmacologic responses to a treatment (biomarker). This qualification provides a tool for more efficient development of devices in a critical area of medicine – traumatic brain injury (TBI) treatment.

• March 6, 2019: From NIH - Opportunity for Funding of Radiation Medical Countermeasures Research - Optional letters of intent are due 30 days before the due date of May 31, 2019.

• March 5, 2019: FDA In Brief: FDA takes new steps to protect food products from deliberate attacks - FDA released a revised draft guidance Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry to support compliance with the intentional adulteration (IA) rule set forth under the FDA Food Safety Modernization Act (FSMA). Also see: Protecting the Food Supply from Intentional Adulteration, such as Acts of Terrorism

• March 5, 2019: HHS’ BARDA Funds Its First Marburg Virus Vaccine Development - To increase national health security against biothreats and protect public health, HHS will partner with Public Health Vaccines LLC of Cambridge, Massachusetts, to develop a potential vaccine against Marburg virus. No licensed vaccine for this virus exists today. The Marburg virus is part of the family of hemorrhagic fever viruses that includes Ebola. The virus causes a similar illness to that of Ebola, and occurs most often in Africa. The Marburg virus was recognized in 1967 and since then multiple outbreaks have occurred with high mortality rates, most recently in 2017. In addition to the threat of naturally occurring infection, the Marburg virus, like Ebola, is deemed a potential bioterrorism threat by the U.S. Department of Homeland Security.

• March 1, 2019: FDA's Critical Role in Ensuring Supply of Influenza Vaccine (Consumer Update) - FDA and the U.S. Department of Health and Human Services (HHS) are working toward developing new and better technologies for producing flu vaccines. As new strains of flu viruses emerge, the FDA works in close coordination with sister agencies, such as the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH), encouraging manufacturers to develop vaccines that will successfully protect us from influenza disease, which can be a very serious illness.

• March 1, 2019: From NIH - NIH Seeking Input on Tickborne Disease Research Priorities - In response to a recommendation by the HHS Tick-borne Disease Working Group, NIAID is forming a new strategic plan to combat tickborne diseases like Lyme disease, Rocky Mountain spotted fever, babesiosis, and Powassan virus. NIAID will be accepting comments and suggestions on the plan from stakeholders in scientific research, advocacy, and clinical practice communities, and from the general public until March 13, 2019.

• February 27, 2019: MCMi email update - New clinical data quality course for high-consequence pathogens | Emergency diagnostics news (PDF, 215 KB) - subscribe (select Emergency Preparedness and Response - FDA Medical Countermeasures Initiative (MCMi) News)

• February 26, 2019: Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s modern approach to advanced pharmaceutical manufacturing - One of today’s most important tools for modernizing the pharmaceutical industry is a process known as continuous manufacturing (CM). This approach transforms the traditional, step-wise manufacturing processes into a single system that’s based on modern process monitoring and controls. It enables a steady output of finished drug products as raw materials are continuously added to the closed system. Today, we’re taking new steps to help advance the adoption of these manufacturing innovations. Also see: Draft guidance - Quality Considerations for Continuous Manufacturing (PDF, 197 KB)

• February 26, 2019: FDA, CDC, and CMS launch task force to help facilitate rapid availability of diagnostic tests during public health emergencies - FDA, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) announced the launch of the Tri-Agency Task Force for Emergency Diagnostics (Charter - PDF, 196 KB). This task force has been created to help leverage the expertise of each agency to advance rapid development and deployment of diagnostic tests in clinical and public health laboratories during public health emergencies. Also see new web pages: Information for Laboratories Implementing IVD Tests Under EUA, and How to Submit a Pre-EUA for In vitro Diagnostics to FDA

• February 22, 2019: NIAID has posted a BAA for research areas including: Development of Radiation/Nuclear Medical Countermeasures, Development of Therapeutic Products for Antibiotic Resistant Bacteria, and Advanced Development of Vaccine Candidates for Antibiotic Resistant Bacteria.

• February 21, 2019: From HHS - New HHS-Sponsored Research Provides New Tool and Updated Guidance on Mass Chemical Decontamination - More than a million first responders and emergency managers in the United States now have a science-based chemical decontamination decision tool and updated guidance on how best to decontaminate a massive number of people after chemical exposure.

• February 14, 2019: FDA's Center for Biologics Evaluation and Research (CBER) is looking for a post-doctoral research fellow to develop vaccines against Ebola, influenza & respiratory syncytial virus (RSV).

• February 13, 2019: MCMi email update - Ebola research update | 2019 funding deadline reminder (PDF, 129 KB) - subscribe (select Emergency Preparedness and Response - FDA Medical Countermeasures Initiative (MCMi) News)

• February 4, 2019: New MCM regulatory science research profile: A new approach for understanding Ebola virus pathogenesis - In late 2018,  FDA awarded a contract to the Broad Institute to conduct the largest Ebola virus and host gene expression study to date. Researchers will use the latest sequencing technologies to assess how Ebola virus evolves and spreads within the body. This work will help fill significant gaps in the scientific community’s understanding of how Ebola virus disease progresses at the molecular level, which will help identify biological pathways and mechanisms that could be useful biomarkers to assess the efficacy of Ebola medical countermeasures, or advance development of potential therapeutics.

• January 29, 2018: The National Association of County and City Health Officials (NACCHO) and the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) are accepting applications for the fourth annual National Health Security Award. This award recognizes local health departments that have demonstrated significant accomplishments in implementing health security-related initiatives within their jurisdictions. Apply by April 26, 2019.

• January 25, 2019: From HHS - Four Ways to Plan to Protect Patient Health in a Medical Supply Shortage (for hospitals and healthcare facilities, from the ASPR Blog)

• January 24, 2019: From NIH - Investigational monoclonal antibody to treat Ebola is safe in adults - The investigational Ebola treatment mAb114 is safe, well-tolerated, and easy to administer, according to findings from an early-stage clinical trial published in The Lancet. Eighteen healthy adults received the monoclonal antibody as part of a Phase 1 clinical trial that began in May 2018 at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland. The National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC), part of NIH, developed the investigational treatment and conducted and sponsored the clinical trial.

• January 17, 2019: FDA in Brief: FDA takes new steps to advance development of antimicrobial susceptibility test devices that help identify appropriate drug treatments for infections and reduce overuse of antibiotics

• January 16, 2019: From HHS - BARDA's DRIVe Ventures has posted an RFI (PDF, 298 KB) to survey the market for venture capital organizations that are capable of managing a sustainable portfolio of medical countermeasure products and technologies to address influenza, emerging infectious diseases and chemical, biological, radiological and nuclear (CBRN) threats. Respond by 5:00 p.m. ET, March 4, 2019.

• January 15,2019: ASPR Releases 2019-2022 National Health Security Strategy to Address 21st Century Threats - ASPR has released an updated quadrennial strategy to safeguard the nation’s health in times of crisis. The 2019-2022 National Health Security Strategy (NHSS) (PDF, 1.4 MB) provides a vision to strengthen the nation’s ability to prevent, detect, assess, prepare for, mitigate, respond to, and recover from disasters and emergencies.  It includes strategies to improve readiness and adapt operational capabilities to address evolving threats such as the use of chemical, biological, radiological, and nuclear (CBRN) weapons; cyber warfare; emerging infectious diseases that could lead to a pandemic; and catastrophic natural disasters and human-caused incidents. Also see: National Health Security Strategy Overview

• January 9, 2019: FDA issued the Sentinel System Five-Year Strategy: 2019-2023 (PDF, 1.7 MB).  This plan lays out the major goals associated with the future of the Sentinel System and FDA Catalyst. It is intended to serve as a roadmap to guide the development of Sentinel over the next five years.

• January 7, 2019: FDA released Advancing Health through Innovation: 2018 New Drug Therapy Approvals (PDF, 2.7 MB), a summary of the Center for Drug Evaluation and Research’s (CDER’s) 2018 important new drug approvals that serve to bring innovative new drug therapies that are safe and effective to patients in need.

2018

• For MCMi news from September 6 - December 31, 2018, please visit this archive page

• For MCMi news from January 1 - September 5, 2018, please visit this archive page

2017

• For MCMi news from 2017, please visit this archive page

2016 and earlier

• For MCMi news from 2010 - 2016, please visit this archive page

Related Links

• MCMi Events Archive
• FDA Newsroom
• MCM-Related Guidance by Date