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  1. CDER Offices and Divisions

Division of Applied Regulatory Science

What We Do

The Division of Applied Regulatory Science (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 CDER products.
  • We develop and evaluate novel tools, standards, and approaches that increase the regulatory efficiency of developing and reviewing safe and effective CDER products.
  • We conduct CDER mission-critical research and review across the translational research spectrum.


Learn More About

  • Our Division - read more about DARS impact on regulatory science in our recent publication.
  • Our Work - find DARS research projects and initiatives in the 2023 DARS Annual Report (PDF - 7.5 MB).

For more information, please contact us at DARS@fda.hhs.gov.

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