Division of Applied Regulatory Science

What We Do

The Division of Applied Regulatory Science (DARS) is within the Office of Clinical Pharmacology (OCP) that is part of the Office of Translational Sciences (OTS).

DARS moves new science into the FDA regulatory process and addresses emergent regulatory and public health questions.

• We tackle challenging scientific questions that impede the development and regulatory evaluation of products that CDER reviews for FDA.
• We develop and evaluate novel tools, standards, and approaches that increase the regulatory efficiency of developing and reviewing safe and effective products that CDER reviews for FDA.
• We conduct critical research and review related to CDER’s mission across the translational research spectrum.

Learn More About

• Our Division - Read our recent publication to learn more about the impact of DARS on regulatory science.
• Our Work - Find research projects and initiatives in the 2025 DARS Annual Report (PDF - 2.6 MB).
• For more information, please contact us at DARS@fda.hhs.gov.