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  1. Counterterrorism and Emerging Threats

Medical Countermeasures Initiative (MCMi)

MCMi is an FDA-wide initiative to coordinate medical countermeasure (MCM) development, preparedness, and response.


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MCMi activities

Gavel and stethoscope, representing medical countermeasure-related counterterrorism legislation

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.

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

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.
Attendees at this annual training focus on the preparation and execution of research clinical trials to facilitate the approval of medical countermeasures for high-consequence pathogens.

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

About MCMi

An FDA-wide initiative to coordinate MCM development, preparedness, and response.
News & events text shown on typewriter

MCMi news and events

MCM and public health emergency news and events from FDA and partners.
MCMi Program Update report cover - FY 2022

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

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

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.
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.

Expiration Dating Extension
Examples of MCMs include drugs, vaccines, and devices, such as diagnostic tests and personal protective equipment.
Examples of MCMs include drugs, vaccines, and devices, such as diagnostic tests and personal protective equipment.

What are Medical Countermeasures?
Robot arm and human hand meet, with gears, representing the concept of advanced manufacturing

Advanced Manufacturing for Public Health Emergency Preparedness and Response

More info for stakeholders

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Contact Us

Contact Point
Michael Mair, MPH
Assistant Commissioner for Counterterrorism Policy, and Director, OCET

AskMCMi@fda.hhs.gov

www.fda.gov/medicalcountermeasures
Twitter: @FDA_MCMi

Hours Available

Office of Counterterrorism and Emerging Threats


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