Emergency Preparedness and Response
Protecting National Health and Security
FDA plays a critical role in protecting the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats. FDA’s responsibility is to ensure that medical countermeasures (MCMs)—such as drugs, vaccines, and diagnostic tests—to counter these threats are safe, effective, and secure.
Working closely with its U.S. government partners through the Department of Health and Human Services’ Public Health Emergency Medical Countermeasures Enterprise (Enterprise), FDA develops and sustains the MCM programs necessary to respond to a public health emergency.
Together with its Enterprise partners, FDA helps to define and prioritize requirements for public health emergency medical countermeasures; coordinate research, set deployment and use strategies for MCMs--and facilitate access to MCMs when necessary.
FDA launches the Medical Countermeasures initiative (MCMi)
In August 2010, FDA launched the Medical Countermeasures initiative (MCMi) to build on the substantive work underway at FDA to foster MCM development and availability. Within FDA's Office of the Chief Scientist, the Office of Counterterrorism and Emerging Threats leads MCMi's implementation in close collaboration with FDA's three medical product centers--CDER, CBER, and CDRH--and the Office of Regulatory Affairs.
MCMi's mission is to: (Pillar I)
(Pillar II) (Pillar III)
FDA's robust engagement with Enterprise partners is establishing clear regulatory pathways for product innovators--based on the most advanced science--to accelerate MCM development.