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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 

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.

For more information about MCMi intramural research at FDA, email AskMCMi@fda.hhs.gov.

FDA staff: Search "OCS intramural challenge grants" on InsideFDA to learn more.

Featured projects archive

Research from these previously featured projects may be ongoing.

FDA Focus Areas of Regulatory Science

The 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 FARS@fda.hhs.gov with questions about this initiative.

More FDA science and research links



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