Extramural Funding Mechanisms

 

Extramural Funding Mechanisms

To expand and complement FDA’s intramural research capabilities and to spur innovation in the field of regulatory science in the extramural community, individual centers/offices as well as OCS, fund extramural research using various contract mechanisms and grants to address Agency regulatory science challenges. Depending on availability of appropriated funds, Centers and FDA may have grant and contract programs to support extramural research in very targeted areas.

OCS supports two FDA-level extramural funding mechanisms. One is a contract mechanism called FDA’s Advancing Regulatory Science Broad Agency Announcement (BAA), which enables FDA to solicit ideas and approaches to facilitate the development and evaluation of FDA-regulated products from industry, academia, and other government agencies in areas where FDA has limited expertise or capacities through this specialized contract mechanism. In the future, the BAA will incorporate the FARS to communicate the Agency’s most current regulatory science needs to solicit relevant proposals from the external scientific community.

FDA also collaborates with academic institutions to advance regulatory science through innovative research, training, and scientific exchange leveraging collaborative grants used to fund the Centers of Excellence in Regulatory Science and Innovation Program (CERSI). Through the CERSI Program, FDA offers its scientific staff a range of opportunities, including research collaborations and access to regulatory science-related training, workshops, and seminars. These opportunities support FDA staff engagement while harnessing a broader community of scientific, technical, and medical expertise within the academic communities in areas of mutual interest in regulatory science. The CERSI Program also provides training opportunities for graduate students and post-graduate fellows to learn about regulatory science, thus creating more awareness in academic institutions about FDA’s research and regulatory programs.

 

 

CROSS-CUTTING TOPICS

Minority Health and Health Equity	Women’s Health	Maternal Health	Pediatric Health
Oncology	Rare Diseases	One Health Initiative

 

EXPLORE THE FOCUS AREAS OF REGULATORY SCIENCE

Advanced Manufacturing	Antimicrobial Resistance	Artificial Intelligence	Biomarkers
Complex Innovative Trial Design	Digital Health Technologies	Empowering Patients and Consumers to Make Better-Informed Decisions	Food Safety
Increasing Access to Complex Generic Drug Products	Individualized Therapeutics and Precision Medicine	Medical Countermeasures and Preparedness for Emerging Infectious Diseases	Microbiome Research
Model-Informed Product Development	Novel Foods and Food Ingredients	Novel Technologies to Improve Predictivity of Non-clinical Studies and Replace, Reduce, and Refine Reliance on Animal Testing	Patient and Consumer Preferences and Perspectives
Patient-Reported Outcomes and other Clinical Outcome Assessments	Product Safety Surveillance	Quality of Compounded Drugs	Regenerative Medicine
	Substance Use Disorders	Technologies to Reduce Pathogen Contamination	Use of Real-World Evidence to Support Biologic, Device, and Drug Development and Regulatory Decision-Making

 

Research Capabilities, Tools, and Resources

Research Management and Collaborations

Technology Transfer and Public-Private Partnerships

Physical Standards and Reference Materials

Intramural Grant Programs

Extramural Funding Mechanisms

Scientific Education, Training, and Communication

Fellowship and Training Opportunities

Professional Development and Continuing Education

Communication and External Meetings

Infrastructure

Facilities and Shared Resources

Safety and Compliance

 

ADDITIONAL ORGANIZATIONAL INFORMATION

Office of the Chief Scientist

Office of Regulatory Science and Innovation

Contact Us: FARS@fda.hhs.gov