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The Center for Biologics Evaluation and Research (CBER) reports performance measures that track progress towards the Center's strategic goals outlined in the 2021-2025 Strategic Plan.
The Biosimilar User Fee Act (BsUFA) authorizes FDA (specifically CBER and the Center for Drug Evaluation and Research (CDER)) 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 CBER and CDER) 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.