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FDA Provides Update on New Drugs Regulatory Program

June 27, 2024


On June 24, 2024, FDA posted a conversation on its website with Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs, regarding the progress of the modernization of the New Drug Regulatory Program (NDRP). NDRP’s modernization goal, which began in 2017, is to increase the efficiency and effectiveness of the processes of the Center for Drug Evaluation and Research (CDER). This initiative was spurred by the ever-increasing growth of genetic science, personalized medicine, and treatments for rare diseases.

According to Tyberg, NDRP began with a diagnostic phase to assess areas in need of improvement. A plan was then developed with six core objectives: scientific leadership; integrated assessment; operational excellence; benefit-risk monitoring; managing talent; and knowledge management. Seven task clusters were also created for achieving the objectives. The plan then moved into the implementation phase.

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