Advancing Regulatory Science
Regulatory Science Programs
Advancing regulatory science through research
Regulatory Science is a field of scientific research focused on developing the tools, standards, and approaches needed to generate the data and information on which FDA assesses the safety, efficacy, quality, and performance of FDA-regulated products. Advances in regulatory science are critical to support regulatory decision-making and to help enable the translation of discoveries in science and technology into safe and effective medical products.
The Office of Regulatory and Emerging Science (ORES) helps advance discovery and innovation in regulatory science by managing FDA-wide programs that provide funding to support intramural and extramural regulatory science and innovation to address scientific and public health priorities. We also fund and conduct regulatory science research and training through these programs. Our work strengthens FDA’s ability to understand and assess risk, prepare for and respond to public health emergencies, and help ensure the safety and effectiveness of FDA-regulated products used by patients and consumers.
IN THIS SECTION
Extramural Regulatory Science - BAA
FDA funds cutting-edge research to advance regulatory science with FDA Broad Agency Announcement (BAA). Learn more apply for funding.
Extramural Regulatory Science - CERSIs
FDA funds innovative approaches to advance regulatory science. Learn more and view projects.
Intramural Regulatory Science Programs
FDA funds research by internal staff to advance the regulatory mission and promote public health. Learn more and view projects.
Focus Areas of Regulatory Science
Explore topics FDA has identified as needing continued targeted regulatory science research.