Advancing Regulatory Science | FDA

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.