MCM Newsletters
The FDA coordinates medical countermeasure development, preparedness and response to help protect the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats.
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Previous editions
2024 | 2023 | 2022 and earlier
Note that links in previous editions may no longer be active.
2024
- October 1, 2024: FDA reorganization effective today | New digital health and AI resource
- September 10, 2024: Medical countermeasure updates: COVID-19 and mpox
- August 20, 2024: Latest HPAI (H5N1) updates from FDA | AI and machine learning update | Clinicians Connect on fall respiratory virus season
- July 23, 2024: Latest HPAI (H5N1) updates from FDA | C. auris test authorized
- June 27, 2024: New medical countermeasures report | Latest HPAI (H5N1) updates from FDA
- June 6, 2024: Platform technology guidance | FDA reorganization update | Latest HPAI (H5N1) updates from FDA
- May 20, 2024: Highly pathogenic avian influenza (H5N1) in dairy cows: National retail dairy product sample results
- May 1, 2024: Highly pathogenic avian influenza (H5N1) in dairy cows | AI and antimicrobial resistance updates
- April 2, 2024: FDA authorizes new long-acting monoclonal antibody for pre-exposure prevention of COVID-19 | New AI paper | Drug shortage updates
- March 5, 2024: FDA works to make informed consent easier to understand | Final guidance on assessing COVID-19 symptoms in clinical trials
- February 12, 2024: Paxlovid expiration date information | Register to attend data quality in BSL-4 labs course
2023
- December 29, 2023: MCMi Update
- November 9, 2023: FDA Clears First COVID-19 Home Antigen Test
- October 16, 2023: FDA Authorizes Updated Novavax COVID-19 Vaccine Formulated to Better Protect Against Currently Circulating Variants
- September 20, 2023: FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants
- August 31, 2023: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants
- August 18, 2023: Registration open for annual training course on achieving data quality and integrity in clinical trials involving high-consequence pathogens
- July 27, 2023: FDA Approves Vaccine for Post-Exposure Prophylaxis of Anthrax
- July 13, 2023: FDA Revises Two Guidances to Extend Enforcement Discretion Policies
- June 30, 2023: FDA Update on Proposal for a Unified Human Foods Program
- June 14, 2023: Join us at the FDA Science Forum today for MCM sessions | Update on antimicrobial resistance
- June 7, 2023: 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
- May 31, 2023: FDA approves first oral antiviral for treatment of COVID-19 in adults
- May 24, 2023: Improving medical product manufacturing capacity and flexibility: new VHA & FDA collaboration
- May 17, 2023: COVID-19 end of PHE reminders | AI discussion paper
- May 10, 2023: End of COVID-19 public health emergency updates | FDA approves first RSV vaccine
- May 3, 2023: Updates on antimicrobial resistance, device cybersecurity, COVID-19 vaccines and tests + more
- April 26, 2023: Join FDA and BARDA April 27 for a workshop: Recombinant Protein-Based COVID-19 Vaccines
- April 19, 2023: FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines | New EUA for COVID-19 at-home test
- April 5, 2023: FDA authorizes a new COVID-19 treatment for certain hospitalized adults | Last chance to pre-register for data quality in BSL-4 labs course
- March 29, 2023: Register now to share your long COVID experience with FDA | Transition plans for COVID-19 related medical devices
- March 22, 2023: COVID-19 and mpox testing updates | Data standards for Animal Rule studies
- March 15, 2023: COVID-19-related guidance documents update | FDA permits marketing of first COVID-19 antigen test using traditional premarket review process
- March 8, 2023: Advanced manufacturing updates | Register now for March and April events
- March 1, 2023: FDA authorizes first over-the-counter at-home test to detect both influenza and COVID-19 viruses
- February 22, 2023: COVID-19 EUA updates | Join us for a March 9 Grand Rounds on microphysiological systems and Zika research
- February 15, 2023: New report: Learn how FDA supports development of & access to medical countermeasures
- February 8, 2023: Report your COVID-19 at-home test results | Now hiring: Regulatory Counsel
- February 1, 2023: COVID-19 therapeutics update: Evusheld not currently authorized in U.S. | Watch out for illegally sold mpox products
- January 25, 2023: Developers of drug and biological products for mpox: new draft guidance | Jan. 26 VRBPAC viewing info.
- January 18, 2023: Regulatory science funding deadline reminder | COVID-19 and mpox updates from FDA
- January 11, 2023: COVID-19 variant updates | Pediatric disease modeling for long COVID
- January 4, 2023: FDA approves treatment for certain hospitalized adults with COVID-19
Newsletter archives
- For MCMi newsletters from 2022, please visit this archive page
- For MCMi newsletters from 2018-2021, please visit this archive page
- For MCMi newsletters from 2017, please visit this archive page
- For MCMi newsletters from 2014-2016, please visit this archive page