MCMi Newsletters

FDA’s Medical Countermeasures Initiative (MCMi) is an agency-wide initiative to coordinate 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 | 2021 and earlier

Note that links in previous editions may no longer be active.

2024

• 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

2022

• December 21, 2022: Vaccine advisory committee meeting on future of COVID-19 vaccines | Understanding at-home OTC COVID-19 antigen diagnostic test results
• December 14, 2022: 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 7, 2022: FDA approves first fecal microbiota product | COVID-19 therapeutic EUA updates
• November 30, 2022: FDA authorizes a COVID-19 and flu point-of-care test | FDA & NIST advanced manufacturing collaboration
• November 22, 2022: Advanced manufacturing updates | Fast facts for health care providers: bivalent COVID-19 vaccines
• November 16, 2022: New funding opportunities | COVID-19 and monkeypox response updates | Modeling & simulation at FDA
• November 9, 2022: Why should I get the updated COVID-19 vaccine now? + COVID-19 therapeutics updates from FDA
• November 2, 2022: Public health emergency response updates from FDA, including COVID-19 and monkeypox
• October 26, 2022: COVID-19 vaccine and therapeutics updates | Monkeypox LDT list
• October 19, 2022: Public health emergency response news from FDA | Regulatory science & funding updates
• October 12, 2022: FDA authorizes bivalent COVID-19 vaccine boosters in younger age groups | First commercial test kit for detection of monkeypox
• October 5, 2022: Latest updates about Evusheld for PrEP for COVID-19
• September 28, 2022: FDA updates COVID-19 test policy | New printable COVID-19 vaccine wall charts including bivalent boosters
• September 21, 2022: New webinar series for monkeypox test developers starts today | Save the date for BAA Industry Day + more news & events
• September 14, 2022: FDA takes significant action to help expand access to monkeypox testing | COVID-19 response updates from FDA
• September 7, 2022: What is a bivalent vaccine? +more COVID-19 booster info, and September/October events
• August 31, 2022: 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 24, 2022: Check your COVID-19 test expiration dates | Monkeypox response updates from FDA
• August 17, 2022: COVID-19 and monkeypox response updates from FDA | Monkeypox vaccine fact sheet in multiple languages
• August 10, 2022: Public health emergency response updates from FDA: COVID-19 and monkeypox updates
• July 20, 2022: COVID-19 response updates from FDA | Monkeypox testing safety communication
• July 13, 2022: FDA authorizes pharmacists to prescribe Paxlovid | Advanced manufacturing job openings
• July 6, 2022: COVID-19 vaccine and therapeutic updates | FDA seeking consumer representatives for advisory committees
• June 29, 2022: Updates from FDA on COVID-19 medical countermeasures, monkeypox testing, advanced manufacturing, and more
• June 22, 2022: FDA authorizes Moderna and Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age
• June 15, 2022: First COVID-19 test to identify specific SARS-CoV-2 lineages authorized
• June 8, 2022: COVID-19 updates from FDA | Collaborating to enhance testing capacity during public health emergencies
• June 1, 2022: June event updates: vaccine advisory committees, register now for July course on clinical trials involving high-consequence pathogens
• May 25, 2022: Updated vaccine advisory committee dates | Know your treatment options for COVID-19
• May 18, 2022: FDA expands eligibility for Pfizer-BioNTech COVID-19 Vaccine booster dose to children 5 through 11 years
• May 11, 2022: COVID-19 response updates from FDA: vaccines, tests, treatments, regulatory science & more
• May 4, 2022: COVID-19 at-home test updates: expiration date extensions, watch out for counterfeit tests
• April 27, 2022: FDA approves first COVID-19 treatment for young children
• April 13, 2022: FDA authorizes more OTC at-home COVID-19 tests | Shelf life extension for a COVID-19 vaccine
• April 6, 2022: EUA updates and FAQs | Watch live today: VRBPAC meeting
• March 30, 2022: FDA authorizes second booster dose of two COVID-19 vaccines for ages 50+ and immunocompromised individuals
• March 23, 2022: COVID-19 test safety information | MCMi job alert: Regulatory counsel
• March 16, 2022: New Medical Countermeasures Initiative report and COVID-19 response infographic
• March 9, 2022: More video FAQs on COVID-19 vaccines | Regulatory science update: 3D tissue chips
• March 2, 2022: COVID-19 testing updates | Revisions to COVID-19 therapeutic EUAs
• February 23, 2022: New resource on at-home OTC COVID-19 tests | MCMi job alert: Interdisciplinary scientist
• February 16, 2022: FDA authorizes new monoclonal antibody that retains activity against omicron | Feb. 22 webinar on transition plans for COVID-19 medical devices
• February 9, 2022: COVID-19 test safety alert | Using real-world evidence to advance COVID-19 medical countermeasures
• February 2, 2022: FDA approves 2nd COVID-19 vaccine | Feb. 15 advisory committee scheduled
• January 26, 2022: FDA takes actions to expand use of treatment for outpatients with mild-to-moderate COVID-19 | At-home diagnostic test updates
• January 19, 2022: Video FAQs about COVID-19 vaccines | Apply by Jan. 21 for regulatory science funding
• January 12, 2022: COVID-19 response updates: tests, vaccines, events, and more
• January 5, 2022: Boosters are now authorized for people 12 years of age and older

Newsletter archives

• 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