Preparedness Research
ORES leads the implementation of FDA’s medical countermeasures regulatory science program.
The FDA plays a critical role in protecting the United States from public health emergencies caused by chemical, biological, radiological, and nuclear (CBRN) threats and emerging infectious diseases, such as Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19)), Ebola, highly pathogenic avian influenza, and mpox. FDA is responsible for reviewing the safety and effectiveness of medical countermeasures (MCMs)—including drugs, therapeutic biological products, vaccines, and devices, such as diagnostic tests—to counter these threats. In addition to its regulatory responsibilities, FDA works closely with U.S. government partners to build and sustain the MCM programs necessary to effectively respond to public health emergencies including with the U.S. Department of Defense (DoD) to facilitate the development and availability of MCMs to support the unique needs of US military personnel.
The Office of Regulatory and Emerging Science (ORES) supports FDA’s public health emergency preparedness and response mission—including the Medical Countermeasures Initiative— by advancing discovery and innovation in regulatory science research and training to develop the tools, standards, and approaches necessary to assess MCM safety, efficacy, quality, and performance and to help translate cutting-edge science and technology into safe and effective MCMs.
In This Section
Extramural MCM Regulatory Science Research
FDA funds Extramural MCM regulatory science research primarily through a Broad Agency Announcement (BAA). Learn more and view current projects.
Intramural MCM Regulatory Science Research
FDA funds Intramural MCM regulatory science through competitive intramural research grants.
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Regulatory Science Research Tools
FDA helps create tools needed to assess MCM safety, efficacy, quality and performance.
Animal Rule Information
Learn more about the Animal Rule which may be used to grant marketing approval of certain products when human challenge studies are not ethical or feasible.