New Drugs Regulatory Program Modernization: Vision, Strategic Objectives, and Impact

Kevin Bugin1, Janet Woodcock2, Peter Stein2

  • 1Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. kevin.bugin@fda.hhs.gov.

Summary

The Food and Drug Administration modernized its New Drugs Regulatory Program to streamline drug review and enhance safety. This initiative improves efficiency and adapts to scientific advancements in drug development.

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