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Regulatory Science at CDER

Overview of CDER science and research goals, programs, and initiatives


Regulatory science at FDA is the science of developing new tools, standards, and approaches to assess the safety and performance of the products it regulates.

CDER's regulatory science activities are aimed at speeding the development of new drugs while ensuring that they are safe and effective. To accomplish this, CDER leads a multifaceted effort that engages scientists from a wide variety of scientific disciplines to pursue five objectives:

  • Develop and improve scientific approaches that aid in developing new drugs or evaluating their pre-market safety and efficacy.
  • Develop and improve scientific approaches to enhance the safety of marketed drugs.
  • Improve product manufacturing, testing, and surveillance to help ensure the availability of high-quality drugs.
  • Develop and improve methods for comparing products to facilitate the development and review of generic drugs and biosimilars.
  • Maintain scientific readiness to address emerging public health threats, enable regulatory integration of emerging technologies, and facilitate stakeholder adoption of novel approaches to drug development.

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