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In this section: Counterterrorism and Emerging Threats

Medical Countermeasures Initiative (MCMi)

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

Sub-Topic Paragraphs

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.

images of FDA-regulated products: blood donation, vaccines, diagnostic tests food, medicines

MCM issues

MCM-related emergency preparedness and response topics, including coronavirus disease (COVID-19), Ebola, antimicrobial resistance, smallpox, and pediatric MCMs.

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.

About MCMi

An FDA-wide initiative to coordinate MCM development, preparedness and response.

MCMi news and events

MCM and public health emergency news and events from FDA and partners.

MCMi FY 20 program update - FDA Medical Countermeasures Initiative

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.

U.S. Food and Drug Administration

Medical Countermeasures Initiative (MCMi)