FDA plays a critical role in protecting the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats. FDA ensures that medical countermeasures (MCMs)—including drugs, vaccines and diagnostic tests—to counter these threats are safe, effective, and secure.
Together with U.S. government partners through the Department of Health and Human Services Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), FDA helps define and prioritize requirements for MCMs in public health emergencies. This includes coordinating research, setting deployment and use strategies, and facilitating access to MCMs.
The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), enacted in 2013, requires FDA to issue an annual report detailing its medical countermeasure activities. This report responds to that requirement for fiscal year (FY) 2017 (October 1, 2016 - September 30, 2017).
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