As part of the Medical Countermeasures Initiative regulatory science program, FDA scientists conduct projects funded through competitive challenge grants.
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
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.
- Decoding Ebola: Next-Generation Sequencing of the Ebola Genome for the FDA-ARGOS Database [ARCHIVED] - Learn more about this ongoing project: Database for Reference Grade Microbial Sequences (FDA-ARGOS)
- Biomarkers for Brain Injury Monitoring [ARCHIVED]
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.