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  1. Public Health Preparedness and Response

Recall Alert

An update on the Cyclospora outbreak available here.

Medical Countermeasures (MCMs)

The FDA coordinates medical countermeasure (MCM) development, preparedness, and response.


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MCM Activities

Gavel and stethoscope

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.

Preparedness Research

Supports FDA’s public health emergency preparedness and response mission—including MCMi— by advancing discovery and innovation in regulatory science research.
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.
Group in professional development session

Outreach and Professional Development

Training courses and activities to help FDA meet the regulatory challenges posed by new science and technology developments.

MCM News and Info

Gavel and test tubes, representing regulatory and scientific components of the Medical Countermeasures Initiative

About MCMs

Learn more about how the FDA coordinates MCM development, preparedness, and response.
Hand holding smartphone with new email notification, with computer in background

Public Health Preparedness and Response Newsletters

Subscribe to receive the latest FDA preparedness and response updates.
MCMi annual program update FY 2023

MCM Initiative Program Update

Learn more about how FDA works every day to protect national health and security, and support public health emergency preparedness.
Supply Chain Security Toolkit for Medical Products

Supply Chain Issues

Information for industry and how the FDA addresses shortages and supply chain disruptions

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 information


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