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The Center for Drug Evaluation and Research (CDER) reports performance measures that highlight its involvement across the life cycle of a drug through policy and science development, pre-approval safety review, and post-approval safety monitoring.
The Biosimilar User Fee Act (BsUFA) authorizes FDA (specifically CDER and the Center for Biologics Evaluation and Research (CBER)) to assess and collect fees for biosimilar biological products. FDA dedicates these fees toward expediting the review process for biosimilar biological products. BsUFA facilitates the development of safe and effective biosimilar products for the American public.
The Prescription Drug User Fee Act (PDUFA) authorizes FDA (specifically CDER and CBER) to assess and collect fees for prescription drug products. FDA dedicates these fees toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities.