MCMi Newsletters
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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
2023 | 2022 | 2021 and earlier
Note that links in previous editions may no longer be active.
2023
- January 25, 2023: Developers of drug and biological products for mpox: new draft guidance | Jan. 26 VRBPAC viewing info.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