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

• November 20, 2024: HPAI H5N1 Bird Flu Updates | Know When to Use Antibiotics
• October 31, 2024: IV Solutions Supply Increasing; Expiration Date Extensions
• October 16, 2024: IV solution supply chain updates | New at-home flu and COVID-19 test
• 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