In 2017, the Center for Drug Evaluation and Research (CDER) initiated the modernization of its New Drugs Regulatory Program (NDRP) to improve efficiency and effectiveness in response to the increasing complexity and volume of drug development. This modernization is fueled by breakthroughs in genetic science, advances in personalized medicine, and a focus on rare diseases. Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs (OND), highlights the initiative’s accomplishments and its impact on public health.

The NDRP modernization involves a comprehensive plan with six core strategic objectives:

  1. Scientific Leadership: Enhance scientific expertise and clarify regulatory approval pathways.
  2. Integrated Assessment: Collaboratively ensure drug approval applications meet legal and regulatory requirements.
  3. Operational Excellence: Standardize processes to improve efficiency and allow scientists to focus on scientific work.
  4. Benefit-Risk Monitoring: Monitor the benefits and risks of approved drugs to protect public health.
  5. Managing Talent: Attract, develop, and retain exceptional personnel.
  6. Knowledge Management: Effectively manage and utilize information.

These efforts aim to continuously improve CDER’s regulatory science and drug review process to better serve public health needs.1

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References

  1. Research, C. F. D. E. A. (2024, June 24). Modernizing the new drugs regulatory program. U.S. Food And Drug Administration. https://www.fda.gov/drugs/cder-conversations/modernizing-new-drugs-regulatory-program

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