MCMi News and Events
Medical countermeasure and public health emergency news and events from FDA and partners
Featured news and events
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Coronavirus Disease 2019 (COVID-19) updates from FDA, including the latest news, FAQs, and more
- FDA has posted the FY23 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science. For funding consideration in FY 2023, submit white papers by 5:00 p.m. EST, January 23, 2023. A recording of the FDA BAA Day held on December 6, 2022 is now available.
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December 21, 2022: FDA approved Actemra (tocilizumab) injection (PDF, 2.6 MB) for treatment of COVID-19 in certain hospitalized adults (FAQs - PDF, 173 KB)
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December 21, 2022: HHS Increases Access to Tamiflu through the Strategic National Stockpile (from HHS)
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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
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December 16, 2022: FDA to Hold Advisory Committee Meeting to Discuss Future Vaccination Regimens Addressing COVID-19 (VRBPAC meeting: January 26, 2023)
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December 14, 2022: New web page: Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results
- MCMi Fiscal Year 2021 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 (1.4 MB).
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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.
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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)
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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
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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
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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.
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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.
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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.
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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
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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
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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.
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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
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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.
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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.
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December 7, 2022: MCMi email - FDA approves first fecal microbiota product | COVID-19 therapeutic EUA updates
View more news in the MCMi News Archive
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Ongoing: Virtual Town Hall Series – Test Development and Validation During Public Health Emergencies (COVID-19 and mpox) - FDA will host regular town halls to share information and answer questions from attendees. Recordings of previous webinars on the policy for mpox tests are available from CDRH Learn, under Specialty Technical Topics. The next event in this series will be held on January 11, 2023.
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January 12, 2023: Virtual Public Listening Session to Identify Ambiguities, Gaps, and Uncertainties in the Coordinated Framework for the Regulation of Biotechnology (webinar, 1:00 p.m. ET) Also see: FDA and Federal Partners Issue Request for Information on the Regulation of Biotechnology
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January 26, 2023: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - The committee will meet in open session to discuss the future vaccination regimens addressing COVID-19, including consideration of the composition and schedule of the primary series and booster vaccinations. Also see: FDA to Hold Advisory Committee Meeting to Discuss Future Vaccination Regimens Addressing COVID-19
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April 24-27, 2023: 2023 Preparedness Summit (Atlanta, GA) - The theme, Recover. Renew: Reprioritizing All-Hazards Preparedness, will provide an opportunity to revisit pressing issues in preparedness and share resources, shape policies, and build skills to mitigate a variety of threats. Registration is now open.
Previous events: MCMi Events Archive
General information
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COVID.gov - Find COVID-19 guidance for your community (a U.S. government website)
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COVID-19 Resources for Health Professionals (updated Oct. 2022)
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Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
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COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders
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FAQs: What happens to EUAs when a public health emergency ends?
Vaccines
- Why should I get the updated COVID-19 vaccine now? (YouTube, Nov. 2022)
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COVID-19 Bivalent Vaccine Boosters (new, August 2022)
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Fast Facts for Health Care Providers: Data Points on the Bivalent COVID-19 Vaccination (PDF, 203 KB) (new, Nov. 2022)
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COVID-19 Vaccine Boosters: Getting the Facts Straight (podcast, April 2022)
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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 2022)
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Learn More About COVID-19 Vaccines (Consumer Update)
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5 Things You Need to Know about the COVID-19 Vaccine for Adolescents 12 through 17 (Consumer Update)
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The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization (PDF, 723 KB)
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#VaccineReady Social Media Toolkit with resources in English and Spanish, from FDA's Office of Minority Health and Health Equity
Therapeutics
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An Update and Behind the Scenes: FDA’s Coronavirus Treatment Acceleration Program
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FDA Updates on Paxlovid for Health Care Providers (May 2022)
Testing
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Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results (new, Dec. 2022)
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A Closer Look at COVID-19 Diagnostic Testing (for health care providers, test purchasers, and public health staff)
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Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs
Regulatory science
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FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data Now Available
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Investing in Advanced Manufacturing to Support Public Health Preparedness
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Extramural research, including projects supporting the COVID-19 response
- 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 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.
- October 6, 2022: FDA is seeking applications for Centers of Excellence in Regulatory Science and Innovation (CERSIs), to conduct collaborative regulatory science research and foster information sharing. Letters of intent are due by October 31, 2022, and applications are due by December 22, 2022.
- September 20, 2022: FDA announced a collaboration with NIH for funding opportunities to support small businesses in developing medical device development tools (MDDTs).
- 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: 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.
Connect with us
View previous editions of the MCMi email newsletter
For more information
MCMi
- MCMi News Archive - MCMi news from 2010 to the present
- MCMi Events Archive - MCMi events from 2010 to the present
- Publications and Reports - including annual MCMi program updates
Emergency use
- Emergency Use Authorization (all current EUAs, including information about amendments)
- Expiration Dating Extension (including the Shelf Life Extension Program, and product-specific information)
- Emergency Use Authorizations (devices)
- MCM Emergency Use Authorities (information about, including EUA)
- Emergency Dispensing Orders and Emergency Use Instructions (EUI)
Guidance and industry information
- MCM-Related Guidance by Date (including comment deadlines, where applicable)
- Guidance and Other Information of Special Interest to MCM Stakeholders (by topic)
- Search for FDA Guidance Documents
Public health emergency response updates and MCM-related issues
- Antimicrobial resistance information from FDA
- Ebola Preparedness and Response
- FDA/DoD Collaborations
- Preparedness Information for Consumers
- More topic-specific pages, including Zika virus, radiological and nuclear emergency preparedness, smallpox preparedness, pediatric MCMs, and MCM monitoring and assessment
Product shortages and availability
- Drug Shortages
- CBER-Regulated Products: Shortages and Discontinuations (vaccines, blood, biologics)
- Drug Shortages Database
- How to report a product shortage or supply issue to FDA
More FDA news and events
- FDA Newsroom - press announcements, fast facts, speeches, and more
- FDA Voices - perspectives from FDA experts