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  5. Preparedness Research
  1. Medical Countermeasures (MCMs)

Preparedness Research

ORES leads the implementation of FDA’s medical countermeasures regulatory science program.

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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.

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 — 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.


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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.
FDA scientist Anjuli Jain conducts an experiment validating nonclinical biomarker models for traumatic brain injury in Dr. Welle’s lab. This research will potentially help establish a regulatory pathway for the use of emerging flexible EEG technologies to rapidly detect brain injury during emergency response situations, such as explosions.
FDA scientist Anjuli Jain conducts an experiment validating nonclinical biomarker models for traumatic brain injury. This research could help establish a regulatory pathway for flexible EEG technologies to rapidly detect brain injury during emergencies.

Intramural MCM Regulatory Science Research

FDA funds Intramural MCM regulatory science through competitive intramural research grants.

More in this section

Qualified Zika test manufacturers can request an FDA reference panel to determine if their tests can differentiate flaviviridae antibodies (Zika, dengue, or West Nile)
Qualified Zika test manufacturers can request an FDA reference panel to determine if their tests can differentiate flaviviridae antibodies (Zika, dengue, or West Nile)

Regulatory Science Research Tools

FDA helps create tools needed to assess MCM safety, efficacy, quality and performance.

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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.

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