FDA Goals for the Center for Drug Evaluation and Research CDER for FDASIA
One of the significant provisions in the recently enacted Food and Drug Administration Safety and Innovation Act (FDASIA) was the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA V). John Jenkins, MD, Director of the Office of New Drugs (OND), in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) recently gave a presentation discussing PDUFA goals, trends in drug approval, and looking ahead....
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