MCMi News Archive

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

Current news & events

2019 | 2018 | 2017 | 2016 and earlier

2019

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

2018

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

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

2017

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

2016 and earlier

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

Related Links

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