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Regulatory Science at CDER

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

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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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