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  1. MCM Regulatory Science
FDA scientist working with lab equipment at FDA headquarters in White Oak, Maryland

Priority research areas | Intramural challenge grants | Featured intramural projects

As part of the Medical Countermeasures Initiative regulatory science program, FDA scientists conduct projects funded through competitive challenge grants.

Priority research areas

  • Developing animal models and tools to evaluate safety and efficacy

  • Identifying and qualifying biomarkers for safety and efficacy

  • Using protein engineering to stabilize vaccine proteins

  • Developing methods to assess medical countermeasure product quality and related product release assays

  • Validating next-generation in vitro diagnostics platforms

  • Assessing the performance of emergency medical equipment

  • Enhancing emergency preparedness and response capabilities, including tracking and evaluating the safety and clinical benefit of medical countermeasures used during public health emergencies

Intramural challenge grants

FDA’s Medical Countermeasures Initiative (MCMi) awards challenge grants to FDA researchers to further research needed to help translate the latest science and technology developments into safe, effective medical countermeasures.

Awarded through a competitive process, these grants help scientists at FDA develop the tools, standards, and approaches FDA needs to assess the safety, efficacy, quality, and performance of medical countermeasures—products that can be used to diagnose, prevent, protect from, or treat conditions associated with  chemical, biological, radiological, or nuclear (CBRN) threats, or emerging infectious diseases.

Featured intramural projects

A monitor in Dr. Welle’s lab shows brain wave activity. (photo: Meijun Ye, FDA)Biomarkers for Brain Injury Monitoring

Recent advances in flexible microelectronics that are wearable and  conformable to the skin bring us closer to a future where portable electroencephalogram (EEG) technology could be used to detect brain injury in victims of traumatic events such as accidents or explosions. To evaluate this new technology for use in humans, FDA needs a scientific knowledge base related to validated brain injury biomarkers  and models. This research could help pave the way for the development of field-deployable devices that can rapidly collect and evaluate EEG signals to diagnose traumatic brain injury.

Scanning electron micrograph of Ebola virus budding from the surface of a Vero cell (African green monkey kidney epithelial cell line). Credit: NIAID/FlickrDecoding Ebola: Next-Generation Sequencing of the Ebola Genome for the FDA-ARGOS Database

When you need a test to confirm disease in an outbreak, you need it fast. Global public health providers need additional infrastructure and tools like rapid diagnostic tests to combat emerging threats, including Ebola and antimicrobial resistant-pathogens. Next-generation sequencing technologies show promise to improve rapid diagnostic tests, and have the potential to speed development of vaccines, therapeutics and diagnostic devices—all of which would enable quicker actions to protect public health.

For more information about MCMi intramural research at FDA, email [email protected].

Center for Biologics Evaluation and Research (CBER) intramural research

FDA Focus Areas of Regulatory Science

The 2021: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) report outlines topics FDA has identified as needing continued targeted investment in regulatory science research to facilitate development of innovative products, provide data and methods to inform regulatory decision-making, and improve guidance to sponsors. Public health preparedness and response is a focus area, including medical countermeasures and preparedness for emerging infectious diseases. Please contact [email protected] with questions about this initiative.

More FDA science and research links


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