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  1. Science and Research | Drugs

Regulatory Science at CDER

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

Regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.

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 three objectives:

  • Create new methods, tools, and analytical approaches that can support and accelerate the evaluation of new drug products.
  • Develop new processes and technologies that help ensure that drug products are manufactured to the highest quality standards.
  • Build information systems and computational tools that can help predict and promptly identify issues with the safety and effectiveness of marketed drugs.


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