Medical Countermeasures Initiative (MCMi)
MCMi is an FDA-wide initiative to coordinate medical countermeasure (MCM) development, preparedness, and response.
MCMi activities
![Gavel and stethoscope, representing medical countermeasure-related counterterrorism legislation](https://public4.pagefreezer.com:443/content/FDA/06-07-2023T01:12/https://www.fda.gov/files/styles/medium_3/public/gavel_stethoscope_1600px.jpg?itok=8H_TTVOw)
MCM legal, regulatory & policy framework
Helping ensure that U.S. laws, regulations and policies support preparedness and response for potential CBRN and emerging infectious disease threats.
![FDA scientist dividing plasma from individuals recently infected with dengue or West Nile viruses into smaller volume samples for distribution. These samples were part of a reference panel FDA created for qualified Zika test manufacturers, to determine if their tests can differentiate flaviviridae antibodies—that is, if the test can accurately show if a person was infected with Zika, dengue or West Nile, as antibodies for these viruses are very similar.](https://public4.pagefreezer.com:443/content/FDA/06-07-2023T01:12/https://www.fda.gov/files/styles/medium_3/public/aliquoting_1600px.jpg?itok=O-wYiqLd)
MCM regulatory science
Developing the tools, standards, and approaches to assess MCM safety, efficacy, quality, and performance, and helping translate new technology into innovative, safe, and effective MCMs.
![Hospital emergency staff, representing public health emergency-related issues](https://public4.pagefreezer.com:443/content/FDA/06-07-2023T01:12/https://www.fda.gov/files/styles/medium_3/public/mcmi-issues.png?itok=LuNNaJpK)
MCM issues
MCM-related emergency preparedness and response topics, including COVID-19, mpox, Ebola, antimicrobial resistance, smallpox, pediatric MCMs, and more.
![Photo montage of students learning in a mock BSL-4 lab with and without BSL hazmat suits on.](https://public4.pagefreezer.com:443/content/FDA/06-07-2023T01:12/https://www.fda.gov/files/styles/medium_3/public/20191211_UTMB_clinical_course_graphic.jpg?itok=SHpY9pwV)
MCMi professional development activities
Training courses and activities to help FDA meet the regulatory challenges posed by new science and technology developments.
MCMi news and info
![Gavel and test tubes, representing regulatory and scientific components of the Medical Countermeasures Initiative](https://public4.pagefreezer.com:443/content/FDA/06-07-2023T01:12/https://www.fda.gov/files/styles/medium_3/public/mcmi-image.png?itok=oZW63wFJ)
About MCMi
An FDA-wide initiative to coordinate MCM development, preparedness, and response.
![News & events text shown on typewriter](https://public4.pagefreezer.com:443/content/FDA/06-07-2023T01:12/https://www.fda.gov/files/styles/medium_3/public/news-events-1600px_0.jpg?itok=LjJF8fiv)
MCMi news and events
MCM and public health emergency news and events from FDA and partners.
![MCMi Program Update report cover - FY 2022](https://public4.pagefreezer.com:443/content/FDA/06-07-2023T01:12/https://www.fda.gov/files/styles/medium_3/public/mcmi-fy22-1600x900%20%282%29.png?itok=4RNvvpr9)
MCMi program update
Learn more about how FDA works every day to protect national health and security, and support public health emergency preparedness.
![6 photos: FDA Commissioned Corps officers donning protecting gowns, gloves, masks and visors; 3D illustration of the coronavirus; cotton facemask; physician wearing medical gloves drawing vaccine or antiviral drug from vial with a syringe; closeup of blood in beaker labeled COVID-19 Positive; closeup of scientist preparing to examine sample under microscope](https://public4.pagefreezer.com:443/content/FDA/06-07-2023T01:12/https://www.fda.gov/files/styles/medium_3/public/COVID-19-Response-Collage-FDA-Voices-1600x900.png?itok=qotVttXd)
COVID-19 updates from FDA
The latest COVID-19 news from FDA, plus frequently asked questions and resources for consumers, health care providers, medical product sponsors, and other stakeholders.
Popular Links
![Emergency sign](https://public4.pagefreezer.com:443/content/FDA/06-07-2023T01:12/https://www.fda.gov/files/styles/medium_3/public/eua-page-1600x900-final.jpg?itok=AnLsxesc)
Emergency Use Authorization (EUA)
![Pharmacist checking medicine boxes on a shelf, representing expiration date extension. In some cases, testing has shown that certain properly stored medical products can be used beyond their labeled expiration date if they retain their stability.](https://public4.pagefreezer.com:443/content/FDA/06-07-2023T01:12/https://www.fda.gov/files/styles/medium_3/public/expiration-dating-extension-1600x900_0.png?itok=1yBwIrA6)
Expiration Dating Extension
![Examples of MCMs include drugs, vaccines, and devices, such as diagnostic tests and personal protective equipment.](https://public4.pagefreezer.com:443/content/FDA/06-07-2023T01:12/https://www.fda.gov/files/styles/medium_3/public/what-are-mcms-banner-final-web.jpg?itok=hs3_OIAi)
What are Medical Countermeasures?
![Robot arm and human hand meet, with gears, representing the concept of advanced manufacturing](https://public4.pagefreezer.com:443/content/FDA/06-07-2023T01:12/https://www.fda.gov/files/styles/medium_3/public/adv-manufacturing-about2-1600x900.jpg?itok=2Xcqryob)
Advanced Manufacturing for Public Health Emergency Preparedness and Response
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Contact Us
Assistant Commissioner for Counterterrorism Policy, and Director, OCET