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 impedes 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.

 

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