MCMi News Archive

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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

2023 | 2022 | 2021 and earlier

2023

June 14, 2023: MCMi email - Join us at the FDA Science Forum today for MCM sessions | Update on antimicrobial resistance
June 12, 2023: Antimicrobial resistance update - FDA announced that Guidance for Industry (GFI) #263 has been fully implemented and all affected animal drug sponsors opted to either voluntarily change the approved marketing status of certain medically important antimicrobial drugs for animals from over-the-counter (OTC) to prescription (Rx) or to voluntarily withdraw approval of their affected OTC animal drug applications. Animal owners and caretakers will still have access to appropriate antimicrobials to address animal health issues by consulting with a licensed veterinarian. The successful implementation of GFI #263 is an encouraging demonstration of the commitment of animal drug sponsors and veterinarians to support the judicious use of antimicrobials in animals.
June 7, 2023: MCMi email - FDA permits marketing of first COVID-19 at-home test using traditional premarket review process | Join us for the FDA Science Forum June 13-14
June 6, 2023: FDA Permits Marketing of First COVID-19 At-Home Test Using Traditional Premarket Review Process - FDA granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in nasal swabs from adults with signs and symptoms of upper respiratory infection. This test is the first at-home over-the-counter (OTC) test for COVID-19 to be granted marketing authorization using a traditional premarket review pathway and the first ever at-home test authorized using a traditional premarket review pathway for any respiratory illness.
June 6, 2023: FDA Announces Additional Steps to Modernize Clinical Trials - FDA announced availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections. The updates are intended to help pave the way for more efficient clinical trials to facilitate the development of medical products. FDA is requesting feedback on the draft recommendations and how they should be applied to increasingly diverse trial types and data sources. Submit comments by September 6, 2023.
June 1, 2023: On May 22, 2023, Janssen Biotech, Inc. requested the voluntary withdrawal of the EUA of the Janssen COVID-19 Vaccine. Janssen Biotech, Inc. informed the FDA that the last lots of the vaccine purchased by the U.S. Government have expired, there is no demand for new lots of the vaccine in the U.S., and they do not intend to update the strain composition of this vaccine to address emerging variants. On June 1, 2023, FDA revoked the EUA (PDF, 100KB) for this vaccine. Also see: Emergency Use Authorization--Archived Information
May 31, 2023: FDA approved a second vaccine for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals 60 years and older
May 31, 2023: Hurricane Emergency Preparedness and Medical Devices: Recommendations for Health Care Providers, Device Manufacturers and Distributors (new web page)
May 31, 2023: MCMi email - FDA approves first oral antiviral for treatment of COVID-19 in adults
May 25, 2023: FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults - FDA approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults. Paxlovid manufactured and packaged under the EUA and distributed by HHS will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by today’s approval. Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19. Also see these updated resources: Paxlovid Patient Eligibility Screening Checklist Tool for Prescribers (PDF, 323 KB), Frequently Asked Questions on the EUA for Paxlovid for Treatment of COVID-19 (PDF, 349 KB), and Fact Sheet for Healthcare Providers: EUA for Paxlovid (PDF, 724 KB), (new) approved product label (PDF, 5.1 MB)
May 24, 2023: MCMi email - Improving medical product manufacturing capacity and flexibility: new VHA & FDA collaboration
May 23, 2023: FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria - FDA approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older. According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health, highlighting the high level of need for additional treatment options amid growing global resistance to antimicrobial medicines.
May 22, 2023: FDA and the Veterans Health Administration announced a new collaboration to jointly develop emergency preparedness and response tools and protocols intended to help increase medical product manufacturing capacity and flexibility, and improve resilience of domestic supply chains during emergencies, shortages, and pandemics. A new Memorandum of Understanding (MOU) will help facilitate the development of requirements for trusted networks needed to enable the use of distributed manufacturing and digital stockpiles, which could ultimately enable veterans and civilians to more rapidly access innovative medical products to support their care. This MOU is specific to medical devices and accessories that may be made using advanced and distributed manufacturing methods. Learn more, including descriptions of these advanced manufacturing approaches.
May 17, 2023: FDA issues two draft guidances for industry to support the approval of pediatric drug products - FDA issued two draft guidances for industry entitled, Pediatric Drug Development: Regulatory Considerations – Complying with PREA and Qualifying for Pediatric Exclusivity Under the BPCA and Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations. Both guidances, once finalized, will provide recommendations to support the assessment of pediatric drugs, biological products, and vaccines under the Pediatric Research Equity Act (PREA) and/or the Best Pharmaceuticals for Children Act (BPCA). The guidance documents revise and replace the draft guidance for industry How to Comply with the Pediatric Research Equity Act. Comments on both draft guidances are due by July 17, 2023.
May 17, 2023: MCMi email - COVID-19 end of PHE reminders | AI discussion paper
May 12, 2023: Eleventh Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 - On May 9, 2023, HHS Secretary Becerra signed the 11th amendment to the declaration under the PREP Act for COVID-19 Medical Countermeasures. The Secretary issued this amendment to clarify that COVID-19 continues to pose a credible risk of a future public health emergency, add two new limitations on distribution, extend the time period of coverage for certain Covered Countermeasures and Covered Persons, clarify the time period of coverage for Covered Persons authorized under the Declaration, and extend the duration of the Declaration to December 31, 2024.
May 12, 2023: FDA updated information on medical device shortages to reflect the end of the COVID-19 public health emergency (PHE), including providing answers to questions regarding notifications and guidance under Section 506J of the FD&C Act.
May 11, 2023: DSCSA Exemptions From Certain Requirements Under Section 582 of the FD&C Act for Covered COVID-19 Products (PDF, 323 KB) - In an effort to transition after the end of the COVID-19 PHE and to avoid potential supply chain disruptions that could harm the COVID-19 response and recovery, FDA has granted the exemptions listed in the document from certain requirements under section 582 of the FD&C Act, as added by the Drug Supply Chain Security Act (DSCSA). FDA has determined that these exemptions are appropriate to maintain public health and has determined that these exemptions address prescription drug products approved or authorized by FDA to diagnose, cure, mitigate, treat, or prevent COVID-19.
May 11, 2023: Lessons Learned from COVID-19 Are Informing Preparation for Future Public Health Emergencies - As we reflect on the devastating losses and lasting impacts the COVID-19 pandemic has had worldwide, we will use the lessons we’ve learned to be thoughtful about preparing for future public health emergencies and use the knowledge gained from our experience with COVID-19 to inform our future response efforts.
May 10, 2023: FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing - As with other evolving fields of science and technology, there are challenges associated with AI/ML in drug development, such as ethical and security considerations like improper data sharing or cybersecurity risks. There are also concerns with using algorithms that have a degree of opacity, or algorithms that may have internal operations that are not visible to users or other interested parties. This can lead to amplification of errors or preexisting biases in the data. We aim to prevent and remedy discrimination — including algorithmic discrimination, which occurs when automated systems favor one category of people over other(s) — to advance equity when using AI/ML techniques. To address these concerns, the FDA has released a discussion paper, Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products (PDF, 1.3 MB). Sumit comments by August 9, 2023. To further address the use of AI in drug manufacturing, in February 2023, FDA issued another discussion paper, Artificial Intelligence in Drug Manufacturing (PDF, 1.7 MB), as part of the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative.
May 10, 2023: MCMi email - End of COVID-19 public health emergency updates | FDA approves first RSV vaccine
May 9, 2023: If you missed the April 27, 2023, Recombinant Protein-Based COVID-19 Vaccines Workshop, a recording is now available until June 15, 2023.
May 9, 2023: From HHS: Fact Sheet: End of the COVID-19 Public Health Emergency - Based on current COVID-19 trends, the Department of Health and Human Services (HHS) is planning for the federal Public Health Emergency (PHE) for COVID-19, declared under Section 319 of the Public Health Service (PHS) Act, to expire at the end of the day on May 11, 2023. This fact sheet includes an update on current flexibilities enabled by the COVID-19 emergency declaration and how they will be impacted by the end of the COVID-19 PHE on May 11.
May 5, 2023: FDA permits marketing of first COVID-19 serology tests through de novo pathway - FDA granted marketing authorization of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack for use with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack for use with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator, both manufactured by Ortho-Clinical Diagnostics, Inc. These tests are intended for prescription use only for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma samples collected on or after 15 days post-symptom onset as an aid in identifying individuals who have an adaptive immune response to SARS-CoV-2 from either a recent or prior infection. Serology tests detect the presence of antibodies to SARS-CoV-2 and do not detect the virus itself. This is one reason that serology tests should not be used to diagnose or exclude acute COVID-19 infection. The sensitivity of the tests in early infection is unknown. Negative results do not mean that the tested individual is free from an acute SARS-CoV-2 infection. If acute infection is suspected, diagnostic testing, such as a PCR or antigen test for COVID-19, is necessary.
May 5, 2023: FDA launched a new web page, Antimicrobial Resistance and Medical Devices, to explain how antimicrobial susceptibility test devices are intended to help health care providers identify the correct therapy (antimicrobial agent) to treat specific bacterial or fungal infections and help identify drug-resistant infections for patient care. Antimicrobial susceptibility testing devices sold in the U.S. for use in clinical laboratories must be reviewed and cleared by the FDA’s Center for Devices and Radiological Health (CDRH).
May 4, 2023: FDA Commissioner Dr. Robert Califf and other HHS officials testified at a U.S. Senate Committee on Health, Education, Labor & Pensions hearing, Preparing for the Next Public Health Emergency: Reauthorizing the Pandemic and All-Hazards Preparedness Act.
May 3, 2023: FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine - FDA approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older. RSV is a highly contagious virus that causes infections of the lungs and breathing passages in individuals of all age groups. RSV circulation is seasonal, typically starting during the fall and peaking in the winter. In older adults, RSV is a common cause of lower respiratory tract disease, which affects the lungs and can cause life-threatening pneumonia and bronchiolitis (swelling of the small airway passages in the lungs). According to the U.S. Centers for Disease Control and Prevention (CDC), each year in the U.S., RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older.
May 3, 2023: MCMi email - Updates on antimicrobial resistance, device cybersecurity, COVID-19 vaccines and tests + more
May 2, 2023: FDA Takes Additional Steps to Advance Decentralized Clinical Trials - FDA is taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites. The agency released a new draft guidance that provides recommendations for sponsors, investigators and other stakeholders regarding the implementation of DCTs to advance medical product development and research. Examples of decentralized elements include obtaining laboratory tests at a local facility rather than a research medical center or conducting a clinical follow-up visit in the trial participant’s home using telemedicine. Submit comments on the draft guidance by August 1, 2023. Also see: CDER Conversation: The Evolving Role of Decentralized Clinical Trials and Digital Health Technologies
May 1, 2023: FDA released a new video, Tips for Health Care Facilities: Cybersecurity Incident Preparedness and Response, featuring Dr. Mark Jarrett, Chief Quality Officer from Northwell Health, with the key focus on how to prepare for a cybersecurity event and how to ensure patient safety during a prolonged cybersecurity event. The video also points viewers to supplementary materials on the FDA website to help health care facilities plan. Also see the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, a resource to help health care organizations prepare for medical device cybersecurity incidents that impact device functions.
April 28, 2023: New video: Meet FDA's Chief Scientist, Dr. Namandjé Bumpus (3 minutes)
April 26, 2023: MCMi email - Join FDA and BARDA April 27 for a workshop: Recombinant Protein-Based COVID-19 Vaccines
April 19, 2023: FDA announced availability of a draft guidance for industry, Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment. The purpose of this draft guidance is to provide information and recommendations to assist sponsors and other interested parties in the development of drugs to prevent or treat acute radiation syndrome (ARS) caused by exposure to ionizing radiation from accidental or deliberate events. Generally, drugs developed for such indications will require approval under the regulations commonly referred to as the Animal Rule. Submit comments by July 19, 2023.
April 19, 2023: MCMi email - FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines | New EUA for COVID-19 at-home test
April 18, 2023: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines - FDA amended the EUAs of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
April 14, 2023: HHS Fact Sheet: HHS Announces Intent to Amend the Declaration Under the PREP Act for Medical Countermeasures Against COVID-19 - The end of the COVID-19 public health emergency alone does not automatically terminate PREP Act coverage for countermeasures. This fact sheet explains some of the key planned changes that partners can expect regarding PREP Act coverage as well as some of what will not change in the coming weeks.
April 12, 2023: Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication - FDA is recommending consumers, health care providers, and facilities to not use certain surgical N95 respirators manufactured by O&M Halyard, and to use caution with certain surgical masks and pediatric face masks manufactured by O&M Halyard.
April 5, 2023: FDA issued a draft guidance, Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making. This guidance is the fourth in a series of guidance documents intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform medical product development and regulatory decision-making. This guidance is intended to help clinical trial sponsors in medical product development. The guidance focuses on clinical outcome assessments (COA) issues associated with clinical trial (study) endpoints, design, conduct and analysis and is most relevant to those designing and conducting trials using COAs as well as analyzing and interpreting the trial data. Submit comments by July 5, 2023.
April 5, 2023: FDA announced the availability of a draft guidance to help prevent and mitigate drug shortages: Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients (API) Under Section 506C of the FD&C Act. The purpose of this guidance is to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain finished drugs and biological products as well as certain APIs that may, in turn, help the agency in its efforts to prevent and mitigate drug shortages. While some supply disruptions and product shortages cannot be predicted or prevented, early communication and detailed notifications to FDA from manufacturers play a significant role in decreasing the incidence, impact, and duration of supply disruptions and product shortages. These notifications allow the agency to evaluate the situation and determine an appropriate course of action. Submit comments by June 5, 2023.
April 5, 2023: MCMi email - FDA authorizes a new COVID-19 treatment for certain hospitalized adults | Last chance to pre-register for data quality in BSL-4 labs course
April 4, 2023: FDA authorizes Gohibic (vilobelimab) injection for the treatment of COVID-19 - FDA issued an EUA (PDF, 298 KB) for the use of Gohibic (vilobelimab) injection for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (artificial life support). Also see: Frequently Asked Questions on the Emergency Use Authorization of Gohibic (PDF, 141 KB)
March 29, 2023: FDA Approves First Over-the-Counter Naloxone Nasal Spray - FDA approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use without a prescription. Also see: Access to Naloxone Can Save a Life During an Opioid Overdose
March 29, 2023: FDA issued a guidance for immediate implementation: Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act. FDA generally intends not to issue “refuse to accept” (RTA) decisions for premarket submissions for cyber devices that are submitted before October 1, 2023, based solely on information required by section 524B of the FD&C Act. Instead, the FDA will work collaboratively with sponsors of such premarket submissions as part of the interactive and/or deficiency review process.
March 29, 2023: MCMi email - Register now to share your long COVID experience with FDA | Transition plans for COVID-19 related medical devices
March 24, 2023: FDA has finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). FDA encourages stakeholders to review the two final guidances, attend the upcoming webinar, and reach out to FDA if they have questions or concerns. Read more: FDA Issues Final Guidances to Assist with Transition Plans for COVID-19-Related Medical Devices
March 23, 2023: FDA issued the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development (PDF, 4.1 MB). The Digital Health Technology (DHT) framework document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products. Learn more
March 22, 2023: MCMi email - COVID-19 and mpox testing updates | Data standards for Animal Rule studies
March 17, 2023: FDA issued an EUA (PDF, 257 KB) for the Cue Mpox (Monkeypox) Molecular Test for use in a point-of-care (POC) setting. The Cue Mpox (Monkeypox) Molecular Test is molecular-based test intended to detect monkeypox virus DNA in lesion swab specimens from individuals suspected of mpox by their health care provider. Learn more: Monkeypox (mpox) Emergency Use Authorizations for Medical Devices
March 17, 2023: The FDA Center for Drug Evaluation and Research (CDER) Office of Compliance published its 2022 Annual Report (PDF, 6.3 MB), including a spotlight on the office's activities to support public health emergency response.
March 16, 2023: FDA updated the page Medical Device Shortages During the COVID-19 Public Health Emergency to reflect changes to expected shortage durations for several types of products, and add devices to the device discontinuance list.
March 15, 2023: The HHS Secretary amended the February 4, 2020 determination made pursuant to section 564 of the FD&C Act and determined pursuant to his authority under section 564(b)(1)(C) that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad and that involves a biological agent, namely the novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (SARS-CoV-2).

The four previously-issued section 564 declarations that refer to the February 4, 2020 determination have not been terminated by the Secretary because, among other things, the circumstances described in section 564(b)(1) continue to exist—i.e., COVID-19, a disease attributable to SARS-CoV-2, continues to present a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad. Consistent with section 564(f), the currently-in-effect EUAs issued under those section 564 declarations remain in effect until the earlier of the termination of relevant section 564 declarations under section 564(b), or revocation of the EUAs. Therefore, these EUAs, including for tests, other devices, treatments, and vaccines, continue to remain in effect. Also see: FAQs: What happens to EUAs when a public health emergency ends? and the March 20, 2023, Federal Register notice: COVID-19 Emergency Use Authorization Declaration
March 15, 2023: FDA announced a final guidance, Definitions of Suspect Product and Illegitimate Product for Verification Obligations, as part of the agency’s implementation of the Drug Supply Chain Security Act (DSCSA). The guidance clarifies FDA’s interpretation of specific terms used in the definitions of “suspect product” and “illegitimate product” to assist trading partners in meeting verification obligations (including notification). The specific terms discussed in the guidance are counterfeit, diverted, stolen, fraudulent transaction, and unfit for distribution. This guidance replaces the draft guidance of the same name. The DSCSA establishes requirements for product tracing, verification, and product identification for certain drug products that are distributed in the U.S. to enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. These requirements add safeguards to improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.
March 15, 2023: MCMi email - COVID-19-related guidance documents update | FDA permits marketing of first COVID-19 antigen test using traditional premarket review process
March 14, 2023: FDA Authorizes Bivalent Pfizer-BioNTech COVID-19 Vaccine as Booster Dose for Certain Children 6 Months through 4 Years of Age - FDA amended the EUA of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine.
March 13, 2023: CDER Conversation – The Latest in Drug Shortages - Drug shortages can occur for many reasons, including manufacturing and quality problems, production delays, and product discontinuations. Manufacturers provide FDA with information related to potential drug shortages, and the agency works closely with them to prevent or reduce the impact of shortages. In this CDER Conversation Emily Thakur, CDR, U.S. Public Health Service, Team Leader for the Center for Drug Evaluation and Research (CDER) Drug Shortage Staff, talks about recent drug supply challenges, shares new FDA guidance, and offers solutions to mitigate drug shortages.
March 13, 2023: Expanded Access with Dr. Jacqueline Corrigan-Curay (Q&A with FDA podcast and transcript) - In this podcast, Dr. Jacqueline Corrigan-Curay, Principal Deputy Director of DER, discusses Expanded Access to Investigational Drug Products. CDER’s DDI receives many questions on this topic. In the past year, DDI has responded to over 750 expanded access related inquiries.
March 10, 2023: FDA issued a notice addressing the agency’s COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the COVID-19 public health emergency (PHE) declared under the Public Health Service (PHS) Act, and which of those guidance documents FDA is revising to temporarily continue in effect. This notice follows an announcement from the U.S. Department of Health and Human Services that, based on current COVID-19 trends, the Department is planning for the COVID-19 PHE declared under the PHS Act to expire on May 11, 2023.

Since the start of the COVID-19 PHE [declared under the PHS Act], FDA has been committed to providing timely recommendations and regulatory information to support response efforts. During the COVID-19 PHE declared under the PHS Act, FDA has provided important tools and flexibilities to manufacturers, health care facilities, providers, patients, and other stakeholders. Importantly, the ending of the PHE declared by HHS under the PHS Act will not impact the FDA’s ability to authorize devices (including tests), treatments or vaccines for emergency use. Existing emergency use authorizations (EUAs) for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met. FDA remains committed to providing notice and information to all impacted stakeholders to ensure a smooth transition.
March 9, 2023: The CDER and CBER Drug Development Tool Qualification Project Search database is now available. The database provides information on clinical outcome assessment (COA) projects for which qualification has yet to be determined, including FDA’s decision to accept or not accept the submission, and FDA’s recommendations on further COA development. The database is a great resource for locating similar measurement development efforts and example submissions. Contact COADDTQualification@fda.hhs.gov with questions.
March 9, 2023: FDA recently posted these new videos (YouTube): Do the COVID-19 vaccines make people more susceptible to emerging variants? and Why should I get my child an updated COVID-19 vaccine?
March 8, 2023: FDA permits marketing of first COVID-19 antigen test using traditional premarket review process - FDA granted marketing authorization (PDF, 253 KB) of the Sofia 2 SARS Antigen+ FIA, Sofia SARS Antigen FIA Control Swab Set, intended for prescription use only for the detection of the COVID-19 virus within 6 days of symptom onset and which can be used in a point-of-care setting. The test aids in the diagnosis of COVID-19 for people experiencing symptoms and is to be repeated twice over three days with at least 48 hours between tests.
March 8, 2023: MCMi email - Advanced manufacturing updates | Register now for March and April events
March 7, 2023: CDRH Statement on Emergency Use Authorization of Lucira Health’s COVID-19 & Flu Home Test
March 3, 2023: FDA approved (PDF, 296 KB) a new single-dose prefilled auto-injector presentation of Udenyca (pegfilgrastim-cbqv) to increase survival of adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS) as could occur after a radiological or nuclear event. For more information, see the product label (PDF, 1.3 MB).
March 2, 2023: FDA cleared a commercially available laboratory traumatic brain injury (TBI) blood test, which will provide clinicians with an objective way to quickly assess individuals with mild TBIs, also known as concussions. Abbott's Alinity i TBI lab test offers results in 18 minutes, as compared to the previously approved Banyan BTI test which takes 4 hours, to help health care providers quickly assess concussion and triage patients. For those with negative results, it rules out the need for a CT scan. The test measures two biomarkers in the blood that, in elevated concentrations, are tightly correlated to brain injury. The DoD, through U.S. Army Medical Research and Development Command's (USAMRDC) U.S. Army Medical Materiel Development Activity (USAMMDA), played a critical role in developing this test run on Abbott's i-STAT Alinity platform. Previously, in January 2021, the DoD announced FDA clearance of a field-deployable rapid, handheld TBI blood test, the i-STAT TBI Plasma cartridge, which runs on the same platform.
March 2, 2023: FDA issued a draft guidance, Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens. This guidance provides drug manufacturers with recommendations for developing and implementing potency assays to ensure each lot of monoclonal antibodies (mAbs) or other therapeutic proteins is produced consistently with the potency necessary to achieve efficacy and that potency is maintained over the shelf life of the product. In January 2021, FDA published a guidance specific to potency considerations for mAbs and therapeutic proteins targeting SARS-CoV-2 (the virus causing COVID-19). This draft guidance expands the scope of the January 2021 guidance to include all mAbs and other therapeutic proteins targeting viruses, not just mAbs targeting SARS-CoV-2. Submit comments by May 1, 2023.
March 1, 2023: FDA issued the ICH final guidance, Q13 Continuous Manufacturing of Drug Substances and Drug Products and a discussion paper for stakeholder comment, Discussion Paper: Artificial Intelligence in Drug Manufacturing (PDF, 1.7 MB). These documents represent proactive steps FDA is taking to facilitate the pharmaceutical industry’s adoption of these advanced manufacturing technologies. FDA has long supported advanced manufacturing technologies that might improve process quality and address underlying causes of drug shortages and recalls. FDA is asking interested stakeholders to provide input on certain areas of consideration identified in the discussion paper by May 1, 2023.
March 1, 2023: MCMi email - FDA authorizes first over-the-counter at-home test to detect both influenza and COVID-19 viruses
February 27, 2023: FDA's Center for Drug Evaluation and Research (CDER) Division of Applied Regulatory Science published its 2022 Annual Report (PDF, 7 MB), including COVID-19 research updates.
February 24, 2023: FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19 Viruses - FDA issued an EUA (PDF, 290 KB) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes.
February 24, 2023: FDA recently issued EUAs for two additional over-the-counter (OTC) at-home COVID-19 antigen tests: the GenBody COVID-19 Ag Home Test (PDF, 310 KB, manufactured by GenBody, Inc.), and the COVI-Go SARS-CoV-2 Ag Self-Test (PDF, 382 KB, manufactured by Mologic, Inc.). Validation data to support authorization of these tests were gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between FDA and NIH.
February 22, 2023: On February 3, 2023, FDA approved a shelf-life extension of TPOXX (tecovirimat) Injection, 200 mg, from 24 months to 42 months for some lots of TPOXX injection. TPOXX supplied by the Strategic National Stockpile (SNS) does not have an expiration date printed on its label. To determine the expiration date for product received from the SNS, find the lot number on the product label and refer to this table to identify the corresponding expiration date. For additional information, see: Expiration Dating Extension: Mpox and Smallpox Therapeutics.
February 22, 2023: MCMi email - COVID-19 EUA updates | Join us for a March 9 Grand Rounds on microphysiological systems and Zika research
February 15, 2023: FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GSK monoclonal antibody, sotrovimab, from 24 months to 30 months. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.4 MB) and the Letter of Authorization (PDF, 375 KB). The extended expiry date for each lot can be found in Table 1 here. For additional information, see: Expiration Dating Extension: COVID-19 Therapeutics.
February 15, 2023: MCMi email - New report: Learn how FDA supports development of & access to medical countermeasures
February 15, 2023: MCMi Fiscal Year 2022 Program Update - FDA plays a critical role in protecting the United States from chemical, biological, radiological, and nuclear threats, and emerging infectious diseases, like COVID-19 and mpox. This report provides updates on fiscal year 2022 activities FDA-wide to support medical countermeasure-related public health emergency preparedness and response. View the PDF (1.5 MB).
February 10, 2023: FDA issued an EUA (PDF, 299 KB) for the Cepheid Xpert Mpox test for use in a point-of-care (POC) setting. Validation data was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH. The Xpert Mpox test is a real-time polymerase chain reaction (PCR) test intended to detect monkeypox virus DNA in lesion swab specimens from individuals suspected of mpox by their health care provider.
February 10, 2023: Update on Expiration Date Extensions of Certain Lots of Doxycycline Hyclate 100 mg Capsules Held in Strategic Stockpiles (PDF, 221 KB) - On February 1, 2023, FDA issued a memo to government public health and emergency response stakeholders providing an important update about expiration date extensions of certain lots of doxycycline hyclate 100 mg capsules manufactured by West-Ward Pharmaceuticals held in strategic stockpiles for anthrax emergency preparedness and response purposes. Also see: Expiration date extensions of certain lots of doxycycline hyclate
February 9, 2023: FDA updates draft guidance to help increase supply of children’s ibuprofen - FDA has revised the immediately-in-effect guidance on compounding certain ibuprofen oral suspension products. The revision addresses outsourcing facilities providing certain ibuprofen oral suspension products to state-licensed pharmacies (including those within hospitals and health systems) and applicable federal facilities to dispense to patients for home use, following receipt of a valid, patient-specific prescription from a health care provider. FDA published this revision to address continual increased demand for fever and pain-reducing medications outside of hospitals and health systems.
February 8, 2023: Summary report (PDF, 110 KB) of the Dec. 2022 Joint EMA-FDA workshop on the efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants
February 8, 2023: MCMi email - Report your COVID-19 at-home test results | Now hiring: Regulatory Counsel
February 6, 2023: Job opening - Regulatory Counsel (PDF, 322 KB) (Title 21, Cures Band C) - Join the FDA Office of Counterterrorism and Emerging Threats (OCET), offering legal, regulatory, and policy expertise to help support medical countermeasure development and availability. Applications are due by March 15, 2023 (deadline extended).
February 6, 2023: FDA encourages you to voluntarily and anonymously report your positive or negative test results every time you use an at-home COVID-19 test. You can report your test result by going to MakeMyTestCount.org or by using an app or other digital option for self-reporting that may be included with your test. Report each test result only one time. Learn more: Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results
February 3, 2023: FDA cleared an in vitro immunochromatographic device for use as an aid in the diagnosis of inhalation anthrax, intended for use by military personnel, medical, and/or healthcare professionals only. The Active Anthrax Detect Plus Rapid Test is the first point-of-care diagnostic test indicated for testing samples from individuals who have signs and symptoms consistent with inhalation anthrax and a likelihood of exposure; it provides results in about 20 minutes. The De Novo classification for this test was supported in whole or in part with federal funds from HHS/BARDA.
February 3, 2023: FDA cleared the BioFire SPOTFIRE Respiratory (R) Panel, an in vitro diagnostic test used for the simultaneous detection and identification of multiple respiratory viral and bacterial infections in individuals suspected of having COVID-19 or other respiratory tract infections. This test was cleared through the Dual 510(k) and CLIA Waiver pathway, making it the first COVID-19 test to be given a CLIA Waiver.
February 1, 2023: FDA revised the Letters of Authorization for two EUAs, Paxlovid (PDF, 283 KB) and Lagevrio (PDF, 286 KB), to remove the requirement for positive test results to prescribe these products. The agency continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19. However, we recognize that, in rare instances, individuals with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their health care provider as having COVID-19 even if they have a negative direct SARS-CoV-2 viral test result. In such instances, their health care provider may determine that treatment with authorized therapeutics may be appropriate if the patient reports mild-to-moderate symptoms of COVID-19 and is at high risk for progression to severe COVID-19, including hospitalization or death, and the terms and conditions of the product’s authorization are met. Additional information is available on the EUA page.
February 1, 2023: FDA issued a draft guidance for industry, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products. This guidance makes recommendations to sponsors and investigators considering the use of externally controlled clinical trials to show evidence of the safety and effectiveness of a drug. The guidance provides stakeholders with considerations for designing and conducting externally controlled trials that use patient-level data (i.e., information on individual people, such as medical and treatment history) to study the effectiveness and safety of drugs, including threats to the validity of trial results from sources of potential bias. The external data can include data from other clinical trials or from real-world data sources such as registries, electronic health records, or medical claims. This guidance also describes considerations for communicating with FDA and ensuring the agency has access to data from an externally controlled trial. This draft guidance is part of a series of guidances FDA has already published, or plans to publish, as part of the agency’s Real-World Evidence Program and in support of the 21st Century Cures Act and the Prescription Drug User Fee Act. Submit comments by May 2, 2023.
February 1, 2023: MCMi email - COVID-19 therapeutics update: Evusheld not currently authorized in U.S. | Watch out for illegally sold mpox products
January 31, 2023: FAQs: What happens to EUAs when a public health emergency ends? (updated)
January 31, 2023: FDA published a new web page, Illegally Sold Monkeypox (Mpox) Products, and issued warning letters to five companies illegally selling products that claim to cure, treat, mitigate, or prevent human monkeypox (mpox) infection. Images of these products are available on Flickr.
January 26, 2023: FDA announces Evusheld is not currently authorized for emergency use in the U.S. - FDA revised the EUA (PDF) for Evusheld (tixagevimab co-packaged with cilgavimab) to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%. Based on this revision, Evusheld is not currently authorized for use in the U.S. until further notice by the Agency.

Should a patient become infected with SARS-CoV-2 and develop symptoms of COVID-19, they should seek medical attention, including starting treatment for COVID-19 as appropriate. There are several treatments – Paxlovid, Veklury (remdesivir) and Lagevrio (molnupiravir) – that are expected to work against currently circulating variants, and that are authorized or approved to treat certain patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Health care providers should assess whether treatments are right for their patients. Also see: Important prescribing information for health care providers (PDF, 135 KB)

The U.S. Government recommends that facilities and providers with Evusheld retain all product in the event that SARS-CoV-2 variants which are neutralized by Evusheld become more prevalent in the U.S. in the future. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 769 KB) and the Letter of Authorization (PDF, 286 KB). Also see: Expiration Dating Extension - COVID-19 Therapeutics
January 26, 2023: Emergent Recalls Certain RSDL Kits Due to Leak Potential - Emergent is recalling RSDL (Reactive Skin Decontamination Lotion) kits from a specific batch after customers noted that some packets were leaking. The leak in the package could cause the lotion-bearing sponge to be less effective when used to remove or neutralize chemical warfare agents. Users also may be unnecessarily exposed to the lotion from leaked packages. The RSDL kit is an easy-to-open packet containing a sponge soaked with lotion. The RSDL kit is carried by members of the military and is intended to remove and/or neutralize chemical warfare agents and T-2 Toxin from the skin. FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries and/or serious health consequences.
January 25, 2023: MCMi email - Developers of drug and biological products for mpox: new draft guidance | Jan. 26 VRBPAC viewing info
January 20, 2023: FDA issued an immediately-in-effect guidance on compounding certain ibuprofen products in an effort to bolster supply of pediatric ibuprofen amid record high demand. The guidance clarifies FDA’s regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products in outsourcing facilities for administration in hospitals and health systems.
January 19, 2023: FDA announced availability of a draft guidance for industry: Mpox: Development of Drugs and Biological Products. FDA is issuing this guidance to support sponsors in their development of drugs and biological products for mpox. This guidance provides nonclinical, virology, and clinical considerations for mpox drug and biological product development programs, with a focus on recommendations to support initiation of clinical trials. Preventive vaccines are not addressed in this guidance. Submit comments by March 21, 2023.
January 18, 2023: MCMi email - Regulatory science funding deadline reminder | COVID-19 and mpox updates from FDA
January 13, 2023: CDC and FDA Identify Preliminary COVID-19 Vaccine Safety Signal for Persons Aged 65 Years and Older - No change in vaccination practice is recommended. Also see: COVID-19 Vaccine Safety Surveillance
January 12, 2023: FDA made minor updates to two COVID-19 testing guidances to help ensure continued access to tests while encouraging the transition of these important public health tools to traditional premarket review pathways. The updated guidances are:
- Policy for Coronavirus Disease-2019 Tests (Revised); and
- Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised).
The minor updates to these guidances reflect FDA’s intent for the two guidances to remain in effect for the duration of the declaration under section 564 of the Federal Food, Drug, and Cosmetic Act that circumstances exist justifying Emergency Use Authorization (EUA) of in vitro diagnostics for the detection of COVID-19, rather than the duration of the public health emergency determination under section 319 of the Public Health Service Act relating to COVID-19. FDA also made minor edits to the Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests guidance to reflect current information about variants and actions the FDA has taken since the original issuance of this guidance.
January 11, 2023: MCMi email - COVID-19 variant updates | Pediatric disease modeling for long COVID
January 10, 2023: FDA issued an EUA (PDF, 296 KB) to DiaCarta, Inc. for the QuantiVirus MPXV Test Kit for the qualitative detection of DNA from monkeypox [mpox] virus in human lesion swab specimens from individuals suspected of mpox by their health care provider. Emergency use of this test is limited to authorized laboratories. Learn more: Monkeypox (mpox) Emergency Use Authorizations for Medical Devices
January 10, 2023: Pediatric disease modeling for long COVID - In an MCMi Regulatory Science program extramural research project, Children’s Hospital Los Angeles and partners are studying how early inflammatory and tissue responses can predict long-term health consequences of COVID-19 in children.
January 6, 2023: FDA posted an update that the agency is closely monitoring the emergence of the XBB.1.5 subvariant, a SARS-CoV-2 omicron variant that is currently estimated to account for 27% of circulating variants in the U.S. Because of its similarity to variants that are not neutralized by Evusheld (e.g., XBB), FDA does not anticipate that Evusheld will neutralize XBB.1.5. This means that Evusheld may not provide protection against developing COVID-19 for individuals who have received Evusheld and are later exposed to XBB.1.5. However, we are awaiting additional data to verify that Evusheld is not active against XBB.1.5. We will provide further updates as new information becomes available.

Health care providers should inform individuals of the increased risk, compared to other variants, for COVID-19 due to SARS-CoV-2 variants not neutralized by Evusheld. If signs and symptoms of COVID-19 occur, advise individuals to test for COVID-19 and seek medical attention, including starting treatment for COVID-19 as appropriate.
January 4, 2023: MCMi email - FDA approves treatment for certain hospitalized adults with COVID-19

2022

December 29, 2022: FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to add the DxTerity SARS-CoV-2 RT PCR CE Test as a test expected to have reduced performance for the SARS-CoV-2 omicron variant and sub-variants.
December 28, 2022: FDA approved a BLA (1.1 MB) for NexoBrid (anacaulase-bcdb) gel, submitted by MediWound, Ltd, Yavne, Israel. NexoBrid is indicated for eschar removal in adults with deep partial thickness and/or full thickness thermal burns.
December 23, 2022: FDA issued an EUA (PDF, 399 KB) to Beckton, Dickinson and Company for the VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System for the qualitative detection of DNA from monkeypox virus in human lesion swab specimens from individuals suspected of mpox by their health care provider. Emergency use of this test is limited to authorized laboratories. Learn more: Monkeypox (mpox) Emergency Use Authorizations for Medical Devices
December 22, 2022: FDA granted an extension (PDF, 204 KB) of the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine. FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine PBS/Sucrose formulation (supplied in multiple dose vials with purple caps). Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown here, as long as approved storage conditions noted in the updated fact sheet for health care providers (PDF, 1.3 MB) have been maintained.
December 21, 2022: FDA approved a new indication for Actemra (tocilizumab) injection (PDF, 2.6 MB) for the treatment of hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). FDA first issued an EUA for Actemra in hospitalized adult and pediatric patients (2 years of age and older) for the same use on June 24, 2021. Actemra remains authorized for emergency use for the same indication for hospitalized pediatric patients 2 to less than 18 years of age who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. FDA has revised the Letter of Authorization (PDF, 249 KB) and associated fact sheets to remove the population covered under the approved indication. Common side effects of Actemra and the recommended dosage for the approved population are included in the prescribing information (PDF, 2.6 MB). Also see: Revised FAQs on EUA for Actemra for Treatment of COVID-19 (PDF, 173 KB)
December 21, 2022: HHS Increases Access to Tamiflu through the Strategic National Stockpile (from HHS) - HHS/ASPR announced that they are making additional supply of Tamiflu available to jurisdictions to respond to an increased demand for the antiviral during this flu season, including through the Strategic National Stockpile (SNS). Jurisdictions will work with their ASPR Regional Teams to evaluate any requests for Tamiflu through the SNS, ensuring that states, territories, and tribes receive the assistance they need without affecting our nation’s preparedness for a future pandemic flu. Also see from ASPR: Improving Access to Influenza Countermeasures for U.S. Jurisdictions, and from FDA: Expiration Dating Extension - Antivirals
December 21, 2022: MCMi email - Vaccine advisory committee meeting on future of COVID-19 vaccines | Understanding at-home OTC COVID-19 antigen diagnostic test results
December 19, 2022: FDA and Federal Partners Issue Request for Information on the Regulation of Biotechnology - The White House Office of Science and Technology Policy (OSTP) — in coordination with FDA, EPA, and USDA — announced a request for information related to the Coordinated Framework for the Regulation of Biotechnology; comments close February 3, 2023. This action requests relevant data and information to help identify regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology. The request for information seeks case studies and other data that relate to new and emerging biotechnology products. The information provided will help regulatory agencies improve the clarity and efficiency of the regulatory processes for biotechnology products, as described in Executive Order 14081, “Advancing Biomanufacturing and Biotechnology Innovation for a Sustainable, Safe, and Secure Bioeconomy.” OSTP, FDA, EPA, and USDA will hold a virtual listening session on January 12, 2023 (1:00 p.m. ET). To learn how the FDA, EPA, and USDA will work together to implement Executive Order 14081, visit the Unified Website for Biotechnology Regulation.

OSTP also published a request for information on the National Biotechnology and Biomanufacturing Initiative, seeking public input on how advances in biotechnology and biomanufacturing can help achieve goals that were previously out of reach and what steps can be taken to ensure the U.S. has the right research ecosystem, workforce, data, domestic biomanufacturing capacity, and other components to support a strong bioeconomy. Comments close January 20, 2023.
December 16, 2022: FDA to Hold Advisory Committee Meeting to Discuss Future Vaccination Regimens Addressing COVID-19 - On January 26, 2023, FDA will hold a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to consider whether and how the composition for primary doses of the currently available COVID-19 vaccines should be modified and how and whether the composition and schedule for booster doses should be adjusted moving forward.
December 16, 2022: FDA’s Center for Veterinary Medicine released a draft update to guidance for industry (GFI) #152, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern.” The guidance is a tool for assessing the risk of antimicrobial resistance (AMR) in people, which could result from the use of a medically important antimicrobial drug in food-producing animals. The scope and purpose of updated GFI #152 remains the same as the initial version of the guidance issued in 2003, but updates better align with current science and clinical practices in human medicine. The agency will be accepting public comments on the draft guidance until March 20, 2023.
December 14, 2022: New web page: Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results - FDA is providing an easy step-by-step guide to help you decide when and how many times to test for COVID-19, what your test results mean, and what you should do next. FDA-authorized over-the-counter (OTC) at-home COVID-19 tests for self-testing at home or other locations are a fast and convenient COVID-19 testing option.
December 14, 2022: MCMi email - FDA authorizes updated (bivalent) COVID-19 vaccines for children down to 6 months of age | Join EMA & FDA for a Dec. 15 mAb workshop
December 13, 2022: FDA issued an EUA (PDF, 260 KB) to Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.) for the TaqPath Monkeypox/Orthopox Virus DNA Kit, for qualitative detection of DNA from monkeypox (mpox) virus (clade I/II) in human lesion swab specimens from individuals suspected of mpox by their health care provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high complexity tests. For more information, see: Individual EUAs for Molecular Diagnostic Tests for Monkeypox
December 13, 2022: FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to add Luminostics, Inc. Clip COVID Rapid Antigen Test as a test expected to have reduced performance for the SARS-CoV-2 omicron variant and sub-Variants.
December 12, 2022: FDA updated the device shortage list to remove medical gloves (product codes LYY, LYZ, LZA, and LZC). FDA will continue to monitor the supply chain and update the device shortage list and device discontinuance list as new information becomes available. Also see: Medical Gloves for COVID-19
December 8, 2022: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age - FDA amended the EUAs of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age.
December 8, 2022: Voluntary Recall of Three Detect Covid-19 Test Lots - Detect, Inc. is voluntarily recalling specific lots of the Detect Covid-19 Test, a molecular, over-the-counter test used to identify SARS-CoV-2 (the virus that causes COVID-19) in self-collected nasal swabs. The recall affects a total of 11,102 tests shipped to customers from July 26, 2022 through August 26, 2022. There is an increased chance that the tests from certain lot numbers may give false negative results.
December 7, 2022: MCMi email - FDA approves first fecal microbiota product | COVID-19 therapeutic EUA updates
December 6, 2022: FDA issued an EUA for the Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit, a test kit supported by the U.S. Government through the Biomedical Advanced Research and Development Authority (BARDA). The Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating a recent or prior infection, and should not be used to diagnose or exclude an acute SARS-CoV-2 infection.
December 5, 2022: FDA and HHS/ASPR authorized an additional extension to the shelf-life for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld, from 18 months to 30 months. As a result of this extension, some batches may be stored for longer from the labeled date of expiry (see Table 1 here). This extension applies to all unopened vials of Evusheld that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 694 KB) and the EUA Letter of Authorization (PDF, 293 KB).
November 30, 2022: FDA Announces Bebtelovimab is Not Currently Authorized in Any U.S. Region - FDA announced that bebtelovimab is not currently authorized for emergency use in the U.S. because it is not expected to neutralize omicron subvariants BQ.1 and BQ.1.1., according to data included in the EUA Fact Sheet for Healthcare Providers (PDF, 763 KB).
November 30, 2022: MCMi email - FDA authorizes a COVID-19 and flu point-of-care test | FDA & NIST advanced manufacturing collaboration
November 28, 2022: FDA approved a new indication (PDF, 244 KB) for Udenyca (pegfilgrastim-cbqv) to increase survival of adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS) as could occur after a radiological or nuclear event. Udenyca is the fifth FDA-approved medical countermeasure and first biosimilar that is indicated to increase survival in patients exposed to myelosuppressive doses of radiation. For more information, see the product label (PDF, 460 KB).
November 28, 2022: NIH is soliciting proposals for (a) the development of medical countermeasures (MCMs) against radiation injury or, (b) biodosimetry approaches targeting radiation-specific biomarker identification and/or device development to predict acute and/or delayed damage to specific organs and tissues beyond dose assessment through a new BAA announcement. Proposals are due by 3:00 p.m. EST February 27, 2023.
November 23, 2022: New Just a Minute! video: What does the future hold for FDA’s efforts to address COVID? (YouTube)
November 22, 2022: FDA granted an EUA amendment (PDF, 347 KB) to add dizziness to all of the Pfizer-BioNTech COVID‑19 Vaccine Fact Sheets and to update the Fact Sheet for Healthcare Providers Administering Vaccine for 6 months through 4 Years of Age Dilute Before Use (PDF, 2.5 MB) to include new information on effectiveness of a 3-dose primary series in study participants 6 months through 4 years of age.
November 22, 2022: FDA issued an EUA (PDF, 302 KB) for the Lucira COVID-19 and Flu Test for use in a point-of-care (POC) setting, following collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP).
November 22, 2022: MCMi email - Advanced manufacturing updates | Fast facts for health care providers: bivalent COVID-19 vaccines
November 21, 2022: The OCET Advanced Manufacturing Program aims to help FDA develop regulatory science tools and metrics, and facilitate industry adoption of these emerging technologies—especially to improve public health emergency response and supply chain resilience. Today, the Office of Counterterrorism and Emerging Threats (OCET), in the Office of the Chief Scientist, published a new website section with additional information about its advanced manufacturing program, including new pages about the I-TEAM Hub collaboration with HHS/ASPR, a smart design and manufacturing pilot program, and a partnership with the National Institute of Standards and Technology (NIST) to develop and benchmark methods to predict thermal stability of monoclonal antibodies. The section also includes new pages about advanced manufacturing research and projects, and public-private partnerships. The existing Advanced Manufacturing page will continue to include advanced manufacturing news, events, and funding opportunities from across FDA.
November 17, 2022: New Just a Minute! video - Are the new bivalent COVID-19 vaccines safe? (YouTube)
November 16, 2022: New fact sheet - Fast Facts for Health Care Providers: Data Points on the Bivalent COVID-19 Vaccination (PDF, 203 KB - ARCHIVED)
November 16, 2022: MCMi email - New funding opportunities | COVID-19 and monkeypox response updates | Modeling & simulation at FDA
November 16, 2022: FDA published a new report, Successes and Opportunities in Modeling & Simulation for FDA. Computational modeling and simulation are powerful tools that complement traditional methods for gathering evidence about products regulated by FDA. FDA scientists routinely review results from M&S studies submitted by industry and use M&S approaches for scientific research and regulatory decision-making. This report presents a selection of modeling and simulation case studies from across FDA, illustrating how these technologies are playing an important role in helping FDA protect and promote public health.
November 15, 2022: FDA issued an EUA (PDF, 254 KB) to Roche Molecular Systems, Inc. for the cobas MPXV for use on the cobas 6800/8800 Systems (cobas MPXV) (EUA220459) for the qualitative detection of DNA from monkeypox virus in human lesion swab specimens from individuals suspected of monkeypox virus infection by their health care provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high complexity tests. Also see: Monkeypox Emergency Use Authorizations for Medical Devices
November 15, 2022: FDA posted an updated Pfizer-BioNTech COVID-19 Vaccine Presentations Wall Chart (PDF, 596 KB)
November 15, 2022: FDA collaborated with MITRE to update the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, a resource to help health care delivery organizations prepare for cybersecurity incidents. The playbook focuses on preparedness and response for medical device cybersecurity issues that impact the functionality of a medical device.
November 9, 2022: Funding opportunity - Innovation Award: COVID-19 and Health Equity - FDA's Office of Minority Health and Health Equity (OMHHE) has posted a funding opportunity for to COVID-19 research that will strengthen and advance research in minority health and healthy equity, increase understanding of health disparities, and provide future direction for research that will contribute to regulatory decision making. OMHHE is interested in research proposals that will contribute to advancing understanding of COVID and long COVID or post-COVID conditions for racial and ethnic minorities or contribute to informing the continued evaluation of the safety and efficacy of FDA approved products (therapeutics, diagnostics, and vaccines) for the treatment, prevention, or diagnosis of COVID-19. These research proposals should support evaluation of outcomes by demographic data including, but not limited to, ethnicity, race, age, disability and geography. Letters of intent are due by December 6, 2022, and applications are due by January 16, 2023.
November 9, 2022: MCMi email - Why should I get the updated COVID-19 vaccine now? + COVID-19 therapeutics updates from FDA
November 8, 2022: New Just a Minute! video: Why should I get my child an updated COVID-19 vaccine? (YouTube)
November 8, 2022: FDA authorized (PDF, 256 KB) Kineret (anakinra) for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). For more information, see the fact sheets for health care providers (PDF, 626 KB) and patients and caregivers (PDF, 413 KB).
November 4, 2022: FDA Updates on Bebtelovimab - FDA updated the Health Care Provider Fact Sheet (PDF, 763 KB) for bebtelovimab with specific information regarding expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2. This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. Prescribers should monitor CDC regional variant frequency data and refer to the Antiviral Resistance information in the Healthcare Provider Fact Sheet for details regarding specific variants and resistance against SARS-CoV-2 variants in your area, particularly Omicron subvariants BQ.1 and BQ.1.1. Read more
November 4, 2022: FDA granted an extension (PDF, 177 KB) of the shelf-life of the authorized Moderna COVID-19 Vaccine. FDA is extending the expiration date of certain lots of the Moderna COVID-19 Vaccine, as listed in the table here, from 9 months to 12 months when stored at recommended long-term storage conditions of -50 °C to -15 °C. This duration may include up to 30 days of storage at 2 °C to 8 °C and up to 24 hours of storage at room temperature (25 °C).
November 3, 2022: New Just a Minute! video: Why should I get the updated COVID-19 vaccine now? (YouTube)
November 2, 2022: MCMi email - Public health emergency response updates from FDA, including COVID-19 and monkeypox
November 1, 2022: FDA revised the EUAs of all COVID-19 antigen tests to revise the authorized uses and require updates to product labeling regarding repeat, or serial, testing. This action is in response to available data about the performance of COVID-19 antigen tests showing that repeat testing after a negative COVID-19 antigen test result increases the chance of an accurate result in people with and without symptoms and could help prevent people from unknowingly spreading the SARS-CoV-2 virus to others.
October 31, 2022: Monkeypox response: FDA launched a new web-based application for single-patient emergency use IND requests for Tembexa, a therapeutic option for patients with human monkeypox disease who meet specific eligibility criteria. Additional information about Tembexa is available at FDA Monkeypox Response: Therapeutics.
October 31, 2022: FDA announced a Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. FDA is implementing this pilot program to facilitate CMC readiness for selected Center for Biologics Evaluation and Research (CBER)- and Center for Drug Evaluation and Research (CDER)-regulated products with accelerated clinical development timelines. For sponsors participating in the pilot, FDA will provide product-specific CMC advice during product development, to include two additional CMC-focused Type B meetings, as well as a limited number of additional CMC-focused discussions, based on readiness and defined CMC milestones.
October 28, 2022: FDA and HHS/ASPR announced the authorization of an additional extension to the shelf life from 18 months to 24 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use.
October 27, 2022: HHS/ASPR published the Public Health and Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan 2022. The plan includes an updated list of PHEMCE high-priority threats.
October 26, 2022: MCMi email - COVID-19 vaccine and therapeutics updates | Monkeypox LDT list
October 20, 2022: FDA updated its Monkeypox and Medical Devices page to provide lists of certain laboratories that have notified the FDA of their laboratory developed monkeypox diagnostic test, modification to an FDA-cleared or EUA-authorized monkeypox diagnostic test, or laboratory developed monkeypox serology test, as described in Sections IV.A.2, IV.A.3, and IV.C, respectively, of the Policy for Monkeypox Tests to Address the Public Health Emergency. While FDA has not reviewed the laboratory’s validation of the listed tests and has not issued EUAs for these tests, we are providing this information to promote transparency.
October 20, 2022: Frequently Asked Questions on the Emergency Use Authorization for Evusheld (tixagevimab co-packaged with cilgavimab) for Pre-exposure Prophylaxis (PrEP) of COVID-19 (PDF, 262 KB) have been updated to include answers to questions including: Is Evusheld still an appropriate option for eligible patients? (in light of SARS-CoV-2 circulating variants), and Are people who have received Evusheld eligible to receive COVID-19 treatments if they develop COVID-19?
October 19, 2022: FDA authorized use (PDF, 892 KB) of Novavax COVID‑19 Vaccine, Adjuvanted as a first booster dose to the following individuals at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine, and revised the fact sheets to reflect these changes:
- Individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and
- Individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.
October 19, 2022: MCMi email - Public health emergency response news from FDA | Regulatory science & funding updates
October 18, 2022: FDA issued an EUA (PDF, 328 KB) for the first over-the-counter saliva-based molecular test to Aptitude Medical Inc. for their Metrix COVID-19 Test, a single-use molecular diagnostic test for the detection of SARS-CoV-2.
October 18, 2022: HHS news release - HHS Announces Actions to Counter Biological Threats, Enhance Pandemic Preparedness, and Achieve Health Security - HHS announced actions the department will take following National Security Memorandum 15, signed by President Biden, directing implementation of the 2022 National Biodefense Strategy and Implementation Plan for Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security (PDF, 547 KB). The strategy and implementation plan detail a coordinated approach to address the challenges from naturally occurring, deliberate, and accidental biological threats. These threats are among the most serious threats facing the U.S. and the international community. The 2022 strategy builds on the 2018 National Biodefense Strategy, incorporating lessons learned during the COVID-19 pandemic, and laying out a comprehensive implementation plan with bold, concrete actions to transform our health security.
October 18, 2022: FDA granted an extension (PDF, 203 KB) for the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine. FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine PBS/Sucrose formulation (supplied in multiple dose vials with purple caps). Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown here, as long as approved storage conditions noted in the updated fact sheet for health care providers (PDF, 2.6 MB) have been maintained.
October 13, 2022: FDA and other agencies are collaborating with NASA on a research project to extend the life of 3D tissue chips, which will allow longer-term studies to help scientists better understand disease models, and inform drug development and clinical trial design. NASA announced the teams of researchers working to extend the tissue chip longevity to study a wide variety of biological changes including neurotoxic stressors, radiation exposure, and acute and chronic exposures to drugs.
October 13, 2022: FDA's Center for Drug Evaluation and Research (CDER) has issued a discussion paper, Distributed Manufacturing and Point-of-Care Manufacturing of Drugs. This discussion paper presents areas associated with distributed manufacturing (DM) and point-of-care (POC) manufacturing that FDA has identified for consideration as FDA evaluates our existing risk-based regulatory framework as it applies to these technologies. The discussion paper does not constitute guidance; instead, its purpose is to gather feedback from the public to inform future policy development. The discussion paper considers relevant background, including terminology, to the FDA’s regulation of DM and POC, identifies challenges presented by DM and POC, and poses key questions to facilitate public comment. FDA is seeking input on each of these topics and on 20 questions posed in the discussion paper. FDA encourages stakeholders to provide comments under docket number FDA-2022-N-2316, by December 13, 2022. Also see: CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative and FDA Seeks Feedback on Distributed and Point-of-Care Drug Manufacturing
October 12, 2022: Jiangsu Well Biotech Co., Ltd. Recalls COVID-19 Ag Rapid Test Devices That Are Not Authorized, Cleared, or Approved by the FDA - Jiangsu Well Biotech Co., Ltd. is recalling COVID-19 Ag Rapid Test Devices because they were distributed to U.S. customers without authorization, clearance, or approval from the FDA. The company has not provided the FDA with adequate validation data to show that the test’s performance is accurate. This means there is a risk of potential false negative, false positive, or misinterpretation of results.
October 12, 2022: MCMi email - FDA authorizes bivalent COVID-19 vaccine boosters in younger age groups | First commercial test kit for detection of monkeypox
October 12, 2022: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups - FDA amended the EUAs of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups. The Moderna COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to five years of age.
October 7, 2022: First commercial test kit authorized for detection of monkeypox - FDA issued an EUA (PDF, 250 KB) to Abbott Molecular, Inc., for the Alinity m MPXV, a real-time polymerase chain reaction (PCR) test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection. The Alinity m MPXV test is the first commercial test kit to be authorized for detection of monkeypox. The Alinity m MPXV test is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of PCR and in vitro diagnostic procedures and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high complexity tests.
October 7, 2022: The White House released the National Strategy for Advanced Manufacturing (PDF, 1 MB). Goals of the strategy are to 1) Develop and implement advanced manufacturing technologies, 2) Grow the advanced manufacturing workforce, and 3) Build resilience into manufacturing supply chains and ecosystems. Learn more about advanced manufacturing at FDA
October 5, 2022: MCMi email - Latest updates about Evusheld for PrEP for COVID-19
October 4, 2022: FDA Launches Biosimilar Regulatory Science Program - As outlined in the biosimilar user fee act (BsUFA) reauthorization commitment letter (PDF, 205 KB) for fiscal years 2023-2027 (BsUFA III), FDA will pilot a regulatory science program to further advance biosimilar and interchangeable biological product development. The program will focus on enhancing regulatory decision-making and facilitating science-based recommendations in areas foundational to biosimilar and interchangeable product development.
October 3, 2022: Latest information and updates about Evusheld for PrEP for COVID-19 - FDA added important information to the authorized Fact Sheets for Evusheld (tixagevimab co-packaged with cilgavimab) to inform health care providers and individuals receiving Evusheld of the increased risk for developing COVID-19 when exposed to variants of SARS-CoV-2 that are not neutralized by Evusheld. Detailed neutralization data can be found in the revised authorized Fact Sheet for Healthcare Providers (PDF, 697 KB). Health care professionals should inform patients of this risk and advise patients who develop signs or symptoms of COVID-19 to test for SARS-CoV-2 infection and promptly seek medical attention, including starting treatment for COVID-19, as appropriate if they test positive.
September 29, 2022: Why is FDA allowing intradermal delivery of the monkeypox vaccine? (new Just a Minute! video with CBER Director Dr. Peter Marks)
September 28, 2022: MCMi email - FDA updates COVID-19 test policy | New printable COVID-19 vaccine wall charts including bivalent boosters
September 27, 2022: FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types - FDA updated its COVID-19 test policy to ensure continued access to tests while encouraging the transition of these important public health tools to traditional premarket review pathways. The updated policy describes the FDA’s intent to review only a small subset of new emergency use authorization (EUA) requests for diagnostic tests and encourages developers of all test types interested in marketing authorization to pursue authorization through the de novo classification or 510(k) clearance pre-market review pathways. Also see: FAQs on Testing for SARS-CoV-2
September 21, 2022: Monkeypox response: New and recently updated Just a Minute! videos:
- When it comes to vaccines, what does intradermal mean? (YouTube) (new)
- Is there a vaccine to prevent monkeypox? How does it work? (YouTube) (updated)
September 21, 2022: Health care providers: Printable wall charts updated to include the COVID-19 vaccine bivalent booster presentations are now available:
- Available Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) Presentations (PDF, 497 KB)
- Currently Available Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine, Bivalent Presentations (PDF, 512 KB)
September 21, 2022: The Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Recipients and Caregivers (PDF) for use in individuals 12 years of age and older, including bivalent booster information, is now also available in Chinese (Simplified), Korean, Spanish, Tagalog, and Vietnamese.
September 21, 2022: MCMi email - New webinar series for monkeypox test developers starts today | Save the date for BAA Industry Day + more news & events
September 20, 2022: FDA announced a collaboration with NIH for funding opportunities to support small businesses in developing medical device development tools (MDDTs).
September 15, 2022: Fast Facts on the Intradermal JYNNEOS Monkeypox Vaccine (PDF, 194 KB) is now available in Chinese (Simplified), Korean, Spanish, Tagalog, and Vietnamese
September 14, 2022: The U.S. Department of Health and Human Services (HHS) announced actions the department will take following the Executive Order signed September 12, 2022 by President Biden launching a National Biotechnology and Biomanufacturing Initiative (NBBI). In its implementation of the Executive Order, HHS intends to leverage biotechnology and biomanufacturing in order to achieve medical breakthroughs, reduce the overall burden of disease, and improve health outcomes. HHS will lead the U.S. government in strategically advancing biosafety and biosecurity innovation as part of a growing bioeconomy, to ensure biotechnology research and development and biomanufacturing infrastructure break new ground while reducing risk. This includes supporting development of the Advanced Manufacturing Innovation Hub in the FDA’s Office of Counterterrorism and Emerging Threats (OCET) to facilitate creation of regulatory science benchmarks and strategies for platform technologies and to drive collaborations that affect multiple product areas (e.g., smart manufacturing, closed loop process controls).
September 14, 2022: MCMi email - FDA takes significant action to help expand access to monkeypox testing | COVID-19 response updates from FDA
September 12, 2022: Monkeypox response: FDA released additional information in publicly posted reviews supporting approval of the new drug application for tecovirimat to describe specific changes in the VP37 proteins of orthopoxviruses (e.g., vaccinia virus and monkeypox virus) that are associated with tecovirimat drug resistance. FDA is releasing this information to aid the scientific community’s genomic sequencing efforts to support national surveillance of the current monkeypox virus outbreak in the U.S. We believe this additional information will further facilitate the ability to monitor for the development and spread of tecovirimat-resistant virus and therefore is important in promoting public health. Additional information on FDA’s response to the public health emergency, including summary information on tecovirimat drug resistance, is available at: FDA Monkeypox Response. Also see from CDC: Guidance for Tecovirimat Use Under Expanded Access Investigational New Drug Protocol during 2022 U.S. Monkeypox Outbreak (September 15, 2022)
September 12, 2022: FDA reissued the August 19, 2022, letter of authorization (PDF, 863 KB) for Novavax COVID-19 Vaccine, Adjuvanted to revise the conditions of authorization related to the Vaccine Adverse Event Reporting System (VAERS) reporting requirements for vaccination providers and Novavax, Inc. to include myocarditis and pericarditis. Because some cases of myocarditis or pericarditis following vaccine administration may not meet the definition of serious adverse events, this change will help ensure that cases of myocarditis and pericarditis are reported by Novavax, Inc. and vaccination providers to VAERS. The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (PDF, 1.3 MB) has also been revised to include information about this updated reporting requirement.
September 9, 2022: FAQs on Testing for Monkeypox - New page with answers to frequently asked questions relating to the development and performance of tests for monkeypox, primarily intended for monkeypox test developers
September 8, 2022: NIH seeks the next generation of COVID-19 diagnostics - The National Institutes of Health has issued two new funding opportunities for diagnostic test manufacturers to develop the next generation of COVID-19 tests, with a major focus on accessibility. The funding opportunities are part of the Rapid Acceleration of Diagnostics (RADx) Tech program, managed by the National Institute of Biomedical Imaging and Bioengineering (NIBIB). The new programs may award up to $300 million in funds from the American Rescue Plan Act of 2021 to support the accelerated development of tests and provide regulatory guidance during the COVID-19 pandemic and beyond. More from NIH: RADx^® Tech and ATP Programs
September 7, 2022: Monkeypox Update: FDA Takes Significant Action to Help Expand Access to Testing - FDA issued guidance that outlines the agency’s current thinking regarding enforcement policies, recommendations for EUA requests for monkeypox diagnostic tests, and the FDA’s plans to prioritize review of EUA requests. The agency is also providing voluntary templates that test developers may use when validating a test or when submitting an EUA request. In addition to the guidance, FDA issued the first EUA (PDF, 464 KB) for a monkeypox in vitro diagnostic. Also see:
- Monkeypox and Medical Devices (new page)
- Monkeypox Emergency Use Authorizations for Medical Devices (new page)
- Emergency Use Authorization - Monkeypox In Vitro Diagnostics EUAs (new section)
- HHS Secretary Becerra Issues 564 Declaration to Expand the Availability of Testing for Monkeypox (HHS press release)
September 7, 2022: MCMi email - What is a bivalent vaccine? +more COVID-19 booster info, and September/October events
September 7, 2022: The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative established the Independent Test Assessment Program (ITAP) to accelerate regulatory review and availability of high-quality, accurate, and reliable over-the-counter COVID-19 tests to the public. ITAP is accepting new proposals on a rolling basis to address the diagnostic needs of the monkeypox outbreak. ITAP support will help accelerate the validation, regulatory authorization, and commercialization of point-of-care (POC) and home monkeypox virus tests. Proposals for POC and home tests that can directly detect the monkeypox virus and kits for at-home monkeypox virus self-collection are being accepted as of September 7, 2022. NIBIB will consider applications only from test manufacturers with existing technologies for monkeypox virus that can quickly scale production and meet FDA's performance/quality standards. More information is available on the submission portal.
September 6, 2022: FDA Authorizes Shelf Life Extension for Certain Lots of Paxlovid - FDA and HHS/ASPR authorized an extension to the shelf life from 12 months to 18 months for certain lots of the Pfizer antiviral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use). As a result of this extension, lots of Paxlovid with dates of expiry from July 2022 to May 2023 may be stored for an additional six months from the labeled date of expiry (see Table 1 here) when stored according to the storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.3 MB).
September 6, 2022: FDA safety communication: Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices - Also see the related letter to health care providers
September 6, 2022: FDA published the 2022 Focus Areas of Regulatory Science (FARS) report, which outlines topics the agency has identified as needing continued targeted investment in regulatory science research to facilitate the development of innovative products, provide data and methods to inform regulatory decision-making and improve guidance to sponsors. Public health preparedness and response is a focus area, including medical countermeasures and preparedness for emerging infectious diseases.
September 2, 2022: FDA posted new Just a Minute! videos with CBER Director Dr. Peter Marks including, What is in the authorized updated (bivalent) COVID-19 boosters? and Why should I get one of the updated COVID-19 vaccine boosters?
September 2, 2022: In August, FDA approved a New Drug Application (NDA) for the use of Midazolam Injection, 10 mg/0.7 mL, autoinjector, for the treatment of status epilepticus in adults. The Department of Defense (DoD) developed the product with Rafa Laboratories, Ltd. According to JPEO-CBRND (the U.S. Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense), the autoinjector "improves upon and will replace the currently fielded convulsant antidote for nerve agent (CANA) diazepam autoinjector." For more information, see the NDA approval letter (PDF, 302 KB) and product label (PDF, 913 KB).
September 1, 2022: FDA posted new Just a Minute! videos with CBER Director Dr. Peter Marks including, What is a bivalent vaccine? and What data support the use of the updated COVID-19 boosters?
September 1, 2022: FDA Voices: Using A Whole-Of-Governments Approach to Combating Illicit Health Products, including fraudulent COVID-19 products
August 31, 2022: MCMi email - FDA authorizes Moderna, Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose | Media call today at 10:45 a.m. ET
August 31, 2022: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose - FDA amended the EUAs of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. The bivalent vaccines, which we will also refer to as “updated boosters,” contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older. Also see: COVID-19 Bivalent Vaccine Boosters (new page)

With this authorization, FDA has also revised the EUAs of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to remove the use of the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines for booster administration for individuals 18 years of age and older and 12 years of age and older, respectively. These monovalent vaccines continue to be authorized for use for administration of a primary series for individuals 6 months of age and older as described in the letters of authorization.
August 29, 2022: Important Information for Human Cell, Tissue, and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Monkeypox Virus and HCT/P Donation
August 26, 2022: FDA Removes N95 Respirators from Medical Device Shortage List, Signaling Sufficient Supply - FDA announced the removal of N95 respirators from the agency’s medical device shortage list, signaling that demand or projected demand for this type of face protection device commonly used in health care settings no longer exceeds the supply. This action is the result of increased domestic manufacturing of N95 respirators, as well as updates to the FDA’s supply chain assessment based on engagement with industry and federal stakeholders, and the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health’s (NIOSH) approval of new disposable N95s and reusable respirators. Also see: Supplies of Medical Devices for COVID-19: Frequently Asked Questions
August 26, 2022: FDA updated Frequently Asked Questions on the Emergency Use Authorization of Bebtelovimab for the Treatment of COVID-19 (PDF, 953 KB) to revise information about distribution of this product.
August 26, 2022: FDA updated the Fact Sheet for Health Care Providers (PDF, 1.5 MB) for Lagevrio (molnupiravir) to link to the most current information for health care providers related to medical conditions and factors associated with increased risk for progression to severe COVID-19.
August 26, 2022: FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19. Prescribers should review each patient’s full list of medications and use other resources to evaluate for potential drug interactions in patients who take medications that are not included on the Fact Sheet or checklist at this time (a listing of additional resources is provided at the end of the checklist). Please see the updated Paxlovid Patient Eligibility Screening Checklist and Drug Interaction Tool (PDF, 995 KB) for more information.
August 26, 2022: The material threat medical countermeasure priority review voucher (MCM PRV) web page has been updated to include a table listing redeemed MCM PRVs.
August 25, 2022: FDA's Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) published its Fiscal Year 2021 Report on the State of Pharmaceutical Quality (PDF, 1.1 MB) to provide information on the quality of the U.S. drug supply and OPQ’s quality surveillance during COVID-19.
August 24, 2022: MCMi email - Check your COVID-19 test expiration dates | Monkeypox response updates from FDA
August 22, 2022: Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to Monkeypox Virus
August 19, 2022: Sentinel Initiative report: Differences in COVID-19 Testing, Positivity, Hospitalization, and Mortality by Race and Ethnicity in the Sentinel Distributed Database: A Descriptive Analysis
August 19, 2022: FDA authorized the emergency use (PDF, 913 KB) of Novavax COVID-19 Vaccine, Adjuvanted for the prevention of Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 17 years of age. This authorization follows a rigorous analysis and evaluation of the safety and effectiveness data conducted by the FDA. The agency previously authorized the vaccine for individuals 18 years and older. Also see the updated fact sheets for recipients/caregivers (PDF, 703 KB) and health care providers (PDF, 1.2 MB).
August 18, 2022: Monkeypox response: FDA Fast Facts: Jynneos (PDF, 222 KB) is now also available in Chinese (Simplified) (PDF, 698 KB), Korean (PDF, 708 KB), Spanish (PDF, 679 KB), Tagalog (PDF, 669 KB), and Vietnamese (PDF, 769 KB).
August 18, 2022: Intradermal Jynneos Monkeypox Vaccine Fast Facts (PDF, 200 KB)
August 18, 2022: Report: FDA's Work to Combat the COVID-19 Pandemic (PDF, 4.9 MB) - Outlines much of the broad range of work the FDA is undertaking to combat the COVID-19 pandemic and prepare for future emergencies.
August 17, 2022: National Center for Toxicological Research (NCTR) Research Highlight: Monitoring SARS-CoV-2 and Its Variants in Arkansas Wastewater
August 17, 2022: MCMi email - COVID-19 and monkeypox response updates from FDA | Monkeypox vaccine fact sheet in multiple languages
August 16, 2022: Monkeypox response: FDA granted an EUA amendment (PDF, 133 KB) for changes to preparation and storage instructions on the Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization of Jynneos (Smallpox and Monkeypox Vaccine, Live, Non-Replicating) for Prevention of Monkeypox Disease in Individuals Determined to be at High Risk for Monkeypox Infection (PDF, 343 KB). Once thawed, the vaccine may be kept at +2°C to +8°C (+36°F to +46°F) for 8 weeks. To get the most 0.1 mL doses for intradermal use from each vial make sure to use low dead volume needles and syringes.
August 16, 2022: Monkeypox response: The Jynneos vaccine EUA fact sheet for recipients and caregivers is now available in five additional languages.
August 12, 2022: Monkeypox response: FDA Fast Facts: TPOXX (PDF, 655 KB) is now also available in Chinese (Simplified) (PDF, 649 KB), Korean (PDF, 659 KB), Spanish (PDF, 634 KB), Tagalog (PDF, 631 KB), and Vietnamese (PDF, 721 KB).
August 12, 2022: Information for Blood Establishments Regarding the Monkeypox Virus and Blood Donation
August 11, 2022: At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication - FDA is advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test, to reduce the risk an infection may be missed (false negative result) and to help prevent people from unknowingly spreading the SARS-CoV-2 virus to others. The FDA recommends repeat testing following a negative result whether or not you have COVID-19 symptoms.
August 10, 2022: MCMi email - Public health emergency response updates from FDA: COVID-19 and monkeypox updates
August 9, 2022: Monkeypox Update: FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply
August 9, 2022: White House Fact Sheet: Biden Administration Announces Key Actions and Implementation Plan to Increase Vaccine Supply
August 9, 2022: HHS press release - HHS Secretary Becerra issues 564 determination, paving way for emergency use authorization of monkeypox vaccines - Also see: Determination of a Public Health Emergency or Significant Potential for a Public Health Emergency and Declaration that Circumstances Exist Justifying and Authorization Pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)
August 8, 2022: FDA approved a New Drug Application (NDA) for the use of Midazolam Injection, 10 mg/0.7 mL, autoinjector, for the treatment of status epilepticus in adults. The Department of Defense (DoD) developed the product with Rafa Laboratories, Ltd. According to JPEO-CBRND (the U.S. Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense), the autoinjector "improves upon and will replace the currently fielded convulsant antidote for nerve agent (CANA) diazepam autoinjector." For more information, see the NDA approval letter (PDF, 302 KB) and product label (PDF, 913 KB).
August 5, 2022: New web page: Rumor Control - The growing spread of rumors, misinformation and disinformation about science, medicine, and the FDA, is putting patients and consumers at risk. We’re here to provide the facts.
August 2022: Funding Opportunity Announcement: Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments - FDA seeks to continue a robust, collaborative, and educational program using problem-based learning techniques designed to bring researchers and regulators together to educate each other on the challenges related to these issues and to identify solutions that are acceptable from both scientific and regulatory perspectives. This program consists of the continued development and implementation of a certified, academic training course for instruction in Good Laboratory Practices (GLP) in a Biosafety Level (BSL) 4 High Containment Environment. Applications are due by 11:59 p.m. ET, October 3, 2022.
July 29, 2022: FDA Provides Update on Agency Response to Monkeypox Outbreak - Also see: FDA Monkeypox Response and Key Facts About Monkeypox Vaccine
July 29, 2022: FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GSK monoclonal antibody, sotrovimab, from 18 months to 24 months.
July 27, 2022: Increasing Agility, Digital Integration in FDA-Regulated Manufacturers - Digital manufacturing institute MxD conducted a study to help FDA understand how and why companies are making decisions to implement digital technology in their operations.
July 26, 2022: Paxlovid shelf-life extension - When FDA first issued the EUA authorizing Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use), it established a 12-month product shelf-life. Four lots of Paxlovid manufactured prior to the EUA issuance were labeled with a 9-month expiry. FDA has authorized extended expiration dates for these lots to reflect the 12-month product shelf-life (see Table 1: Extended Expiry Dating for Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use) Authorized under EUA 105), when stored according to the storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for EUA 105 for Paxlovid.
July 22, 2022: FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to include information about genotyping tests authorized for the identification and differentiation of specific SARS-CoV-2 mutations, lineages, or variants.
July 20, 2022: New Q&A with FDA Podcast Series: Conversation on Paxlovid and COVID-19
July 20, 2022: MCMi email - COVID-19 response updates from FDA | Monkeypox testing safety communication
July 19, 2022: FDA updated the device shortage list and the device discontinuance list on the web page Medical Device Shortages During the COVID-19 Public Health Emergency. In addition, the FDA is providing information about devices that have been removed from the device shortage list at this time. FDA also updated the Supplies of Medical Devices for COVID-19: Frequently Asked Questions web page to provide information about how the FDA determines to remove product codes from the device shortage list and what the FDA is doing to help medical device manufacturers with the global shortage of semiconductor chips.
July 15, 2022: For Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication
July 15, 2022: HHS orders additional vaccine, increases testing capacity to respond to monkeypox outbreak (HHS press release) - The FDA recently announced that it has completed its inspection of the Bavarian Nordic manufacturing facility in Denmark. Observations from inspections inform FDA’s evaluation of other quality information submitted by sponsors, which are critical to helping ensure vaccines’ safety and effectiveness. Doses from the facility can potentially be approved by the end of July, which would mean that approximately 780,000 additional doses would be added to the government’s available supply.
July 14, 2022: FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to include information about genotyping tests authorized for the identification and differentiation of specific SARS-CoV-2 mutations, lineages, or variants.
July 13, 2022: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted - FDA issued an EUA (PDF, 899 KB) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. Also see: Novavax COVID-19 Vaccine
July 13, 2022: MCMi email - FDA authorizes pharmacists to prescribe Paxlovid | Advanced manufacturing job openings
July 12, 2022: Apply to join the Office of Counterterrorism and Emerging Threats (OCET) Advanced Manufacturing team, to help advance public health emergency preparedness and patient access to medical products through development of tools and approaches to enhance the evaluation of advanced manufacturing technologies and facilitate their adoption by regulated industries. Apply by August 1, 2022. For more information see the Staff Fellow job announcements:
- OCET Research Engineer (PDF, 159 KB) (General Engineer)
- OCET Research Scientist (PDF, 146 KB) (General Health and Medical Sciences)
July 8, 2022: FDA approved COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 15 years of age. The approval follows a rigorous analysis and evaluation of the safety and effectiveness data conducted by FDA. The Pfizer-BioNTech COVID-19 Vaccine has been, and will continue to be, authorized for emergency use in this age group since May 2021. COMIRNATY (COVID-19 Vaccine, mRNA) has been approved for use in individuals 16 years of age and older since August 2021.
July 6, 2022: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations - The FDA revised the Emergency Use Authorization (EUA) (PDF, 783 KB) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. Also see: Frequently Asked Questions on the Emergency Use Authorization for Paxlovid for Treatment of COVID-19 (PDF, 995 KB)
July 6, 2022: MCMi email - COVID-19 vaccine and therapeutic updates | FDA seeking consumer representatives for advisory committees
July 1, 2022: 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. For advisory committee vacancies listed in this notice, and those that may occur through December 31, 2023. Nomination materials are due by August 15, 2022.
June 30, 2022: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses and new web page: Update: COVID-19 Vaccine Booster Composition
June 29, 2022: FDA authorizes revisions to Evusheld dosing to recommend repeat dosing every six months with a dose of 300 mg of tixagevimab and 300 mg cilgavimab if patients need ongoing protection
June 29, 2022: MCMi email - Updates from FDA on COVID-19 medical countermeasures, monkeypox testing, advanced manufacturing, and more
June 28, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. FDA granted this extension following a thorough review of data submitted by AstraZeneca. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry. This extension applies to all unopened vials of Evusheld that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 712 KB) and the EUA Letter of Authorization (PDF, 293 KB) for Evusheld. As required by the EUA, of Evusheld (150 mg/1.5 mL of tixagevimab and 150 mg/1.5 mL of cilgavimab), must be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
June 28, 2022: An FDA Self-Audit of Continuous Manufacturing for Drug Products (podcast and newsletter) - Continuous manufacturing (CM) technology has the potential to improve product quality and reliability, lower manufacturing costs, reduce waste, decrease inventory, and increase manufacturing flexibility and agility in response to product demand. Alternatively, is it possible that CM can also increase time to regulatory approval and market entry, hinder submission of post-approval changes, and raise inspectional scrutiny? CDER’s Office of Pharmaceutical Quality (OPQ) set out to find answers by conducting a self-audit of approved U.S. regulatory submissions that employ CM vs. traditional batch processes, and analyzing regulatory outcomes during the product lifecycle and at approval.
June 27, 2022: FDA's Center for Drug Evaluation and Research published its 2021 Office of New Drugs Annual Report (PDF, 8.5 MB), including efforts during the second year of the COVID-19 pandemic, specifically related to trial designs for COVID-19 therapies, collaboration with drug sponsors, and issuance of guidances addressing the impact of emergent variants on drug development.
June 27, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 24 months to 30 months for specific lots of the refrigerated Regeneron monoclonal antibodies, casirivimab and imdevimab, administered together, or REGEN-COV. Due to the high frequency of the omicron variant and its subvariants, REGEN-COV is not currently authorized in any U.S. region. Therefore, REGEN-COV may not be administered for treatment or post-exposure prevention of COVID-19 under the EUA until further notice by the Agency. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to bamlanivimab and etesevimab, emerge and become prevalent in the United States. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.7 MB) and the EUA Letter of Authorization (PDF, 1 MB).
June 22, 2022: MCMi email - FDA authorizes Moderna and Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age
June 17, 2022: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age - For the Moderna COVID-19 Vaccine, the FDA amended (PDF, 1 MB) the Emergency Use Authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older. For the Pfizer-BioNTech COVID-19 Vaccine, the FDA amended the EUA (PDF, 1.3 MB) to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older. A recording of the virtual press conference is available (32 minutes).
June 16, 2022: Testimony by FDA Commissioner Dr. Robert Califf: An Update on the Ongoing Federal Response to COVID-19: Current Status and Future Planning
June 15, 2022: MCMi email - First COVID-19 test to identify specific SARS-CoV-2 lineages authorized
June 10, 2022: FDA issued an EUA (PDF, 261 KB) for the Laboratory Corporation of America (Labcorp) VirSeq SARS-CoV-2 NGS Test on the PacBio Sequel II sequencing system. This is the first COVID-19 test to identify specific SARS-CoV-2 lineages. Read more: Individual EUAs for Genotyping Tests for SARS-CoV-2
June 8, 2022: MCMi email - COVID-19 updates from FDA | Collaborating to enhance testing capacity during public health emergencies
June 3, 2022: FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19. Prescribers should review each patient’s full list of medications and use other resources to evaluate for potential drug interactions in patients who take medications that are not included on the Fact Sheet (PDF, 619 KB) or checklist at this time (a listing of additional resources is provided at the end of the checklist). Please see the updated Prescriber Patient Eligibility Screening Checklist (PDF, 279 KB) for more information.
June 1, 2022: In May 2022, FDA, the Centers for Disease Control and Prevention (CDC), and several stakeholders signed a Memorandum of Understanding (MOU) to collaborate on enhancing laboratory testing surge capacity outside of CDC and public health laboratories before and during public health emergencies. Partnerships and engagement between the public and private sector are crucial to supporting a significant increase in demand for diagnostic testing during a public health emergency and to respond to emerging public health threats before reaching the level of a pandemic.
June 1, 2022: MCMi email - June event updates: vaccine advisory committees, register now for July course on clinical trials involving high-consequence pathogens
May 26, 2022: FDA has posted information about Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings in June
May 25, 2022: MCMi email - Updated vaccine advisory committee dates | Know your treatment options for COVID-19
May 23, 2022: Essential Medicines Report Now Available - The nation’s first Essential Medicines Supply Chain and Manufacturing Resilience Assessment by the U.S. government was released by the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR). The assessment addresses pharmaceutical supply chain constraints identified in the Biden-Harris Administration’s 100-day supply chain review report, specifically those constraints affecting critical medicines on the FDA’s essential medicines list. Download the full report here.
May 23, 2022: FDA revised the dates of two upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings due to new data from sponsors and expected submissions of EUA requests. VRBPAC will discuss Moderna’s EUA request for 6 years through 17 years of age on June 14, 2022, and will discuss the Moderna EUA request for 6 months through 5 years of age and Pfizer-BioNTech EUA request for 6 months through 4 years of age on June 15, 2022.
May 20, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use. FDA granted this extension following a thorough review of data submitted by Eli Lilly. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry (see Table 1 here). This extension applies to all unopened vials of bebtelovimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 433 KB) and the EUA Letter of Authorization (PDF, 111 KB) for bebtelovimab. As required by the EUA, unopened vials of bebtelovimab injection, 175 mg/2 mL, must be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
May 18, 2022: FDA approved an intravenous (IV) formulation (PDF, 565 KB) of TPOXX (tecovirimat) to treat smallpox. The oral formulation of the drug was originally approved in 2018. The IV formulation is an option for those who are unable to swallow the oral capsule. Also see: Smallpox Preparedness and Response Updates from FDA
May 19, 2022: FDA urges drug manufacturers to develop risk management plans to promote a stronger, resilient drug supply chain - Also see the draft guidance: Risk Management Plans to Mitigate the Potential for Drug Shortages
May 19, 2022: FDA updated its safety communications and frequently asked questions about the Philips Respironics ventilator, BiPAP machine, and CPAP machine recalls on FDA.gov to provide the latest information about medical device reports associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam.
May 18, 2022: MCMi email - FDA expands eligibility for Pfizer-BioNTech COVID-19 Vaccine booster dose to children 5 through 11 years
May 17, 2022: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years - FDA reissued (PDF, 483 KB) the EUA for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine.
May 16, 2022: FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV
May 16, 2022: Woodside Acquisitions Inc Recalls Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) That Are Not Authorized, Cleared, or Approved by the FDA
May 12, 2022: Statement Regarding Shelf-Life Extension of Sotrovimab (from HHS/ASPR and FDA) – The shelf-life of sotrovimab continues to be evaluated. Due to the high frequency of the omicron BA.2 variant, sotrovimab is not currently authorized in any U.S. region. However, it is recommended that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to sotrovimab, emerge and become prevalent in the United States. All sotrovimab vials may be retained until the shelf-life extension evaluation is complete and posted, regardless of the current labeled expiry date or previously provided extension dates. This recommendation applies to all unopened vials of sotrovimab that have been held in accordance with storage conditions (refrigerated temperature at 2°C to 8°C (36°F to 46°F)) detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.38 MB) and the Letter of Authorization (PDF, 488 KB).
May 10, 2022: MCMi email - COVID-19 response updates from FDA: vaccines, tests, treatments, regulatory science & more
May 9, 2022: Mesa Biotech, Inc., Recalls Certain Accula SARS-CoV-2 Tests for Risk of False Positives Caused by Contamination
May 5, 2022: Wastewater surveillance from SARS-CoV-2 variants (update) - Through the American Rescue Plan Act of 2021, Congress provided temporary funding for FDA to develop the capacity to sequence SARS-CoV-2 RNA from wastewater samples and to conduct a sampling and sequencing project through 2022. To facilitate sharing of information about progress on this sequencing effort, FDA published a public dashboard that graphically presents information from the project. Studies have shown that SARS-CoV-2 (COVID-19) variants of concern from wastewater can be identified 1-2 weeks prior to being detected in clinical samples from the same area, making wastewater surveillance useful for detecting and monitoring SARS-CoV-2 in the population. Raw sequence data plus a standard suite of metadata is available for download.
May 5, 2022: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals - FDA has limited the authorized use (PDF, 299 KB) of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
May 4, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated Eli Lilly monoclonal antibodies, bamlanivimab and etesevimab. Due to the high frequency of the omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S. region. Therefore, these drugs may not be administered for treatment or post-exposure prevention of COVID-19 under the EUA until further notice by the Agency. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to bamlanivimab and etesevimab, emerge and become prevalent in the United States. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 773 KB) and the Letter of Authorization (PDF, 488 KB).
May 4, 2022: FDA posted a new CDER Conversation: FDA Updates on Paxlovid for Health Care Providers, including a new eligibility screening checklist tool (PDF, 247 KB). Paxlovid is the preferred therapy for the management of non-hospitalized adults with COVID-19, according to the National Institutes of Health COVID-19 Treatment Guidelines.
May 4, 2022: MCMi email - COVID-19 at-home test updates: expiration date extensions, watch out for counterfeit tests
April 29, 2022: COVID-19 Vaccine Boosters: Getting the Facts Straight - The FDA Office of Minority Health and Health Equity (OMHHE) has released a new episode of the Health Equity Forum podcast. In the latest episode, RADM Richardae Araojo, FDA's Associate Commissioner for Minority Health and Director of OMHHE, is joined by Dr. Robert Califf, the FDA Commissioner. During this episode, they discuss COVID-19 vaccines and boosters misinformation. You can find the episode on our website (including a transcript) and on Apple Podcasts, Google Podcasts, Spotify, and Pandora.
April 29, 2022: FDA recognizes that consumers and farmers may have questions over recent reports of Highly Pathogenic Avian Influenza (HPAI) outbreaks in the United States. FDA published a short questions and answers web page regarding the safety of eggs during HPAI outbreaks.
April 29, 2022: FDA is aware of counterfeit at-home over-the-counter (OTC) COVID-19 diagnostic tests being distributed or used in the United States. These counterfeit tests should not be used or distributed.
April 29, 2022: FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines - FDA announced plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of complete submissions of EUA requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers.
April 28, 2022: FDA updated the page, At-Home OTC COVID-19 Diagnostic Tests, to include expiration date information to help consumers find the current expiration date for any FDA authorized OTC COVID-19 diagnostic test.
April 27, 2022: MCMi email - FDA approves first COVID-19 treatment for young children
April 26, 2022: On April 26, 2022, FDA granted an extension (PDF, 179 KB) for the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine. FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine PBS/Sucrose formulation (supplied in multiple dose vials with purple caps) from 9 months to 12 months when stored between -90°C to -60°C.
April 25, 2022: FDA Approves First COVID-19 Treatment for Young Children - FDA expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are: hospitalized, or not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As a result of today’s approval action, the agency also revoked the EUA for Veklury that previously covered this pediatric population. Before now, Veklury was only approved to treat certain adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms, which is about 88 pounds) with COVID-19.
April 14, 2022: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples - FDA issued an EUA (PDF, 448 KB) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage. The test is performed by a qualified, trained operator under the supervision of a health care provider licensed or authorized by state law to prescribe tests and can provide results in less than three minutes. Also see the new web page: In Vitro Diagnostics EUAs - Other Diagnostic Tests for SARS-CoV-2
April 13, 2022: Statement Regarding Shelf-Life Extension of Bamlanivimab and Etesevimab (from HHS/ASPR and FDA) - Evaluation of future extension of shelf-life for bamlanivimab and etesevimab is ongoing and an update regarding shelf-life extension for bamlanivimab and/or etesevimab is planned for early May 2022. Therefore, in the interim, all bamlanivimab and etesevimab vials may be retained until the shelf-life extension evaluation is complete and posted, regardless of the current labeled expiry date or previously provided extension dates. More info: Expiration Dating Extension: COVID-19 Therapeutics
April 13, 2022: FDA granted an extension (PDF, 374 KB) for the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine. FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine for the two presentations of the Tris/Sucrose formulation (supplied in multiple dose vials with orange caps and labels with an orange border and in multiple dose vials with gray caps and labels with a gray border). The frozen vials may be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF) for up to 12 months from the date of manufacture.
April 13, 2022: MCMi email - FDA authorizes more OTC at-home COVID-19 tests | Shelf life extension for a COVID-19 vaccine
April 7, 2022: FDA authorized an extension (PDF, 136 KB) for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 11 months. Learn more: Expiration Dating Extensions - COVID-19 Vaccines
April 6, 2022: MCMi email - EUA updates and FAQs | Watch live today: VRBPAC meeting
April 5, 2022: New FAQs: What happens to EUAs when a public health emergency ends?
April 5, 2022: Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the omicron BA.2 sub-variant. CDC Nowcast data from April 5, 2022, estimates that the proportion of COVID-19 cases caused by the omicron BA.2 variant is above 50% in all HHS U.S. regions. Data included in the health care provider fact sheet (PDF, 1.4 MB) show the authorized dose of sotrovimab is unlikely to be effective against the BA.2 sub-variant. Due to these data, sotrovimab is not authorized in any U.S. state or territory at this time. Health care providers should use other approved or authorized products as they choose appropriate treatment options for patients. FDA will continue to monitor BA.2 in all U.S. regions and will provide follow-up communication when appropriate.
March 30, 2022: The U.S. government has launched a new one-stop shop website, COVID.gov, to help all people in the United States gain even better access to lifesaving tools like vaccines, tests, treatments, and masks, as well as get the latest updates on COVID-19 in their area. Learn more: Fact Sheet: Biden Administration Launches COVID.gov, a New One-Stop Shop Website for Vaccines, Tests, Treatments, Masks, and the Latest COVID-⁠19 Information
March 30, 2022: MCMi email - FDA authorizes second booster dose of two COVID-19 vaccines for ages 50+ and immunocompromised individuals
March 29, 2022: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals - FDA authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This action will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization and death. Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns. Also see: Media Call: Second COVID-19 Vaccine Booster Dose (12: 30 p.m. ET, March 29)
March 28, 2022: FDA Seeks $8.4 Billion to Further Investments in Critical Public Health Modernization, Core Food and Medical Product Safety Programs, including pandemic preparedness
March 25, 2022: FDA limits use of sotrovimab to treat COVID-19 in some U.S. regions due to the BA.2 omicron sub-variant - New data included in the health care provider fact sheet (PDF, 1.4 MB) shows that the authorized dose of sotrovimab is unlikely to be effective against the BA.2 sub-variant. Based on CDC Nowcast data, the BA.2 sub-variant is eeestimated to account for more than 50% of cases in the states and territories in HHS Regions 1 and 2 as of March 19, 2022.
March 23, 2022: MCMi email - COVID-19 test safety information | MCMi job alert: Regulatory counsel
March 21, 2022: Philips Respironics Recalls Certain V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm
March 21, 2022: FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters - FDA will hold a Vaccines and Related Biological Products Advisory Committee (VRBPAC) on April 6, 2022, to discuss considerations for future COVID-19 vaccine booster doses and the process for selecting specific strains of the SARS-CoV-2 virus for COVID-19 vaccines to address current and emerging variants
March 18, 2022: Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety Communication - FDA issued a safety communication to alert people of the potential for harm if FDA-authorized at-home COVID-19 tests are not used according to the manufacturer’s test instructions. FDA is also reminding people to keep the tests out of reach from children and pets.
March 17, 2022: New fact sheet: Mitigating and Preventing Medical Device Shortages and Prioritizing Public Health (PDF, 491 KB) - This new fact sheet includes information on the medical device shortages authority and work on shortages undertaken in the FDA’s Center for Devices and Radiological Health (CDRH).
March 16, 2022: MCMi email - New Medical Countermeasures Initiative report and COVID-19 response infographic
March 16, 2022: FDA published the MCMi Program Update report which showcases FDA's work each year to prepare for all types of public health emergencies, including COVID-19. This report, covering fiscal year 2021, includes an update on FDA's COVID-19 response during the reporting period, and a new infographic [ARCHIVED] providing a snapshot of some FDA COVID-19 response actions from the beginning of the public health emergency through the end of FY 2021.
March 10, 2022: FDA Orders Philips Respironics to Notify Patients Regarding the Recall of Certain Breathing Assistance Machines - FDA issued a notification order (PDF, 371 KB) to Philips Respironics requiring the company to notify patients and others of the company’s June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products. The FDA has determined that this order is necessary to eliminate the unreasonable risk of harm posed by the recalled products, because the company’s notification efforts to date have been inadequate.
March 10, 2022: On March 4, 2022, FDA authorized an extension (PDF, 33 KB) for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 9 months. The vaccine was previously authorized to be stored for up to 6 months. This shelf life extension applies to all batches that have been released to the U.S. market, and that have been held in accordance with the manufacturer’s storage conditions. Vaccines that are authorized under an EUA do not have fixed expiration dates, and their expiration dates may be extended based on data submitted by the manufacturers. Health care providers administering the vaccine should check the company’s website (https://vaxcheck.jnj) to obtain the most up-to-date expiration dates for specific lots of the Janssen COVID-19 vaccine.
March 9, 2022: MCMi email - More video FAQs on COVID-19 vaccines | Regulatory science update: 3D tissue chips
March 2, 2022: MCMi email - COVID-19 testing updates | Revisions to COVID-19 therapeutic EUAs
March 1, 2022: NASA, the National Institutes of Health (NIH), the Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), and FDA announced the award of eight contracts in a multi-agency collaboration to extend longevity of complex in vitro (human) models, such as 3D tissue chips and microphysiological systems, to at least six months. Currently, such chips are viable for about one month, limiting researchers’ ability to track longer-term effects of treatments on tissues using these systems. Results from longer studies could be used to better understand disease models, supporting development of and clinical trial design for a variety of medical countermeasures.
March 1, 2022: FDA issued safety communications for 3 COVID-19 tests that people should not use:
- Do Not Use Certain Celltrion DiaTrust COVID-19 Tests
- Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests
- Do Not Use Certain ACON Flowflex COVID-19 Tests
February 25, 2022: FDA updates Sotrovimab EUA - FDA is continually monitoring how authorized and approved treatments for COVID-19 are affected by changing variants—currently Omicron and the Omicron subvariants. On February 23, 2022, FDA revised the emergency use authorization for sotrovimab to clarify that sotrovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a variant that is not susceptible to this treatment. However, sotrovimab is currently authorized in all U.S. regions until further notice by FDA. For other limitations and conditions, refer to the EUA (PDF, 375 KB).
February 24, 2022: FDA authorizes revisions to Evusheld dosing - FDA has revised the EUA (PDF, 899 KB) for Evusheld (tixagevimab co-packaged with cilgavimab) to change the initial dose for the authorized use as pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric patients. Based on the most recent information and data available, Evusheld may be less active against certain omicron subvariants. The dosing regimen was revised because available data indicate that a higher dose of Evusheld may be more likely to prevent infection by the COVID-19 omicron subvariants BA.1 and BA.1.1 than the originally authorized Evusheld dose.
February 24, 2022: HHS news release: HHS Secretary Becerra Highlights Progress Made in Strengthening U.S. Medical Supply Chain and Industrial Base - Health and Human Services Secretary Xavier Becerra issued a new report highlighting the progress that has been made over the past year to strengthen the U.S. public health and medical supply chain and industrial base. The report highlights the U.S. government’s accomplishments in addressing public health and medical supply chain challenges since the beginning of the COVID-19 pandemic, describes how HHS is implementing the recommendations and goals in the National Strategy for a Resilient Public Health Supply Chain, and outlines additional actions the U.S. government can take to build on its progress. Also see the updated FDA page: Executive Order 14017 on America’s Supply Chains
February 23, 2022: MCMi email - New resource on at-home OTC COVID-19 tests | MCMi job alert: Interdisciplinary scientist
February 22, 2022: New resource - At-Home OTC COVID-19 Diagnostic Tests
February 18, 2022: E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results
February 17, 2022: Vyaire Medical Recalls bellavista 1000 and 1000e Series Ventilators Due to Issues with Software Configurations
February 17, 2022: FDA welcomed Robert M. Califf, MD, as Commissioner of Food and Drugs.
February 17, 2022: 3D Printing in Hospitals: Veteran’s Health Administration’s Experiences in Point of Care 3D Printing of Device and Implementing a Quality Management System - FDA is announcing a virtual public workshop on March 16-17, 2022, in collaboration with the Veteran’s Health Administration (VHA) to share VHA’s experiences using 3D printing/additive manufacturing in their hospitals. The workshop is also intended to provide a forum for VHA and other stakeholders to present and discuss their experience that could be useful for health care facilities considering 3D printing medical devices. To attend, register by March 14, 2022.
February 16, 2022: MCMi email - FDA authorizes new monoclonal antibody that retains activity against omicron | Feb. 22 webinar on transition plans for COVID-19 medical devices
February 11, 2022: New web page from FDA's Center for Biologics Evaluation and Research (CBER): International Engagements to Respond to COVID-19 Pandemic
February 11, 2022: FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 That Retains Activity Against Omicron Variant - FDA issued an EUA (PDF, 181 KB) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. The EUA for bebtelovimab is 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, which is about 88 pounds) with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.
February 11, 2022: FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age - FDA has been notified by Pfizer that new data have recently emerged regarding its EUA request for the use of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age. As part of its rolling submission, the company recently notified the agency of additional findings from its ongoing clinical trial. Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization. Therefore, the FDA is postponing the Vaccines and Related Biological Products Advisory Committee meeting originally scheduled for Feb. 15.
February 9, 2022: MCMi email - COVID-19 test safety alert | Using real-world evidence to advance COVID-19 medical countermeasures
February 8, 2022: Because of significant concerns for human safety, FDA issued a guidance, COVID-19 Public Health Emergency: Policy on COVID-19-Related Sanitation Tunnels, to announce a policy discouraging sponsors from developing or seeking approval or authorization for the use of sanitation tunnels, which are tunnels, walkways, chambers, and similar systems that spray humans with a mist of disinfectant or aerosolized antiseptic with the aim of preventing or treating COVID-19.
February 7, 2022: Using real-world evidence to advance COVID-19 medical countermeasures - The rapid assessment of inpatient treatments has emerged as particularly critical for effective COVID-19 care, because the majority of life-threatening cases of COVID-19 are treated in inpatient settings. An FDA-funded extramural research project aims to develop a system of studies for the rapid assessment of the safety and effectiveness of COVID-19 inpatient medical countermeasures using real-world evidence (RWE).
February 4, 2022: FDA issued a guidance, Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic, to help sponsors mitigate the challenges related to the constrained supply of nonhuman primates (NHPs) available for conducting nonclinical toxicity assessments, which has arisen as a consequence of the current COVID-19 pandemic.
February 4, 2022: COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics - The Reagan-Udall Foundation for the FDA, at the request of the FDA, has released a report that outlines initial lessons learned from the federal government’s and research communities’ COVID-19 response and provides actionable recommendations to enhance the scope, prioritization, and communication of research activities within the context of a public health emergency.
February 4, 2022: FDA announced that the comment period for the draft guidance: Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act, published on January 11, 2022, has been extended by 30 days, and will close on April 11, 2022.
February 2, 2022: New web page from FDA's Center for Veterinary Medicine: From House Cats to Big Cats: How FDA Evaluated Methods for Detecting SARS-CoV-2 in Animals
February 2, 2022: MCMi email - FDA approves 2nd COVID-19 vaccine | Feb. 15 advisory committee scheduled
February 1, 2022: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age - The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session on Feb. 15 to discuss the request for EUA of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.
January 31, 2022: FDA Takes Key Action By Approving Second COVID-19 Vaccine - The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older. Spikevax meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality required for approval. Moderna COVID-19 Vaccine has been available under Emergency Use Authorization (EUA) for individuals 18 years of age and older since Dec. 18, 2020.
January 28, 2022: Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication - FDA issued a safety communication warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. These tests were distributed with labeling indicating they are authorized by the FDA, but neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the potentially higher risk of false results when using unauthorized tests. Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, and the FDA has identified this issue as a class I recall, the most serious type of recall.
January 26, 2022: MCMi email - FDA takes actions to expand use of treatment for outpatients with mild-to-moderate COVID-19 | At-home diagnostic test updates
January 24, 2022: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant - As we have throughout the COVID-19 pandemic, FDA has used the best available science as the virus has evolved to make informed decisions with the health and safety of the American public in mind. Ensuring that healthcare providers on the frontlines have the best tools available to treat patients is a top priority for the agency. In light of the most recent information and data available, today, the FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.
January 21, 2022: FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19 - FDA took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease. This provides another treatment option to reduce the risk of hospitalization in high-risk patients. Previously, the use of Veklury was limited to patients requiring hospitalization.
January 19, 2022: UPDATE: Blood Specimen Collection Tube Conservation Strategies - Letter to Health Care and Laboratory Personnel - FDA updated the device shortage list to include all blood specimen collection tubes (product codes GIM and JKA) to the testing supplies and equipment – specimen collection category on the device shortage list. The list previously included sodium citrate (light blue top) tubes only. The device shortage list reflects the categories of devices the FDA has determined to be in shortage at this time. The FDA will continue to update the list as the COVID-19 public health emergency evolves. To mitigate ongoing shortages, FDA is providing blood specimen collection tube conservation strategies.
January 19, 2022: MCMi email - Video FAQs about COVID-19 vaccines | Apply by Jan. 21 for regulatory science funding
January 13, 2022: FDA 2021 Year in Review (PDF, 5.9 MB) - This year-end report highlights key FDA actions in 2021 to protect and improve public health, including a COVID-19 vaccine approval and authorizations of COVID-19 tests and treatments.
January 12, 202: MCMi email - COVID-19 response updates: tests, vaccines, events, and more
January 11, 2022: FDA announced revisions to the Janssen COVID-19 Vaccine Fact Sheet for Heath Care Providers Administering Vaccine (PDF, 1.5 MB) and the Fact Sheet for Recipients and Caregivers (PDF, 776 KB). These revisions are in response to new safety information regarding the serious risk of Immune Thrombocytopenia (ITP), a disorder that can cause easy or excessive bruising and bleeding due to very low levels of platelets, following administration of the Janssen COVID-19 Vaccine.
January 11, 2022: Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication
January 7, 2022: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months - FDA amended the EUA for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.
January 5, 2022: MCMi email - Boosters are now authorized for people 12 years of age and older
January 3, 2022: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine - FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to: 1) expand the use of a single booster dose to include use in individuals 12 through 15 years of age; 2) shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months; and 3) allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age.

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