CDER and the Modernization of the New Drugs Regulatory Program

In 2017, the Center for Drug Evaluation and Research (CDER) initiated the modernization of its New Drugs Regulatory Program (NDRP) to enhance the efficiency and effectiveness of its operations. This modernization effort was prompted by the increasing complexity and volume of drug development, driven by advances in genetic science, personalized medicine, and a focus on rare diseases. The initiative aims to continuously improve the regulatory science and review process for drug applications.

In a CDER Conversation, Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs (OND), discusses the achievements and public health impacts of the modernization. A detailed list of these accomplishments is provided in the NDRP Modernization – Impact Narrative 2023.¹

Read the full text here.

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

Disclaimers

• The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
• Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
• No official support by any organization(s) has been provided or should be inferred

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