FDA Medical Product User Fee Reauthorization: In Brief

Summary

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The Food and Drug Administration (FDA) regulates human medical products to ensure they are safe and effective for their intended use in patients. Medical products include prescription and nonprescription (over-the-counter) drugs, biologics or biological products, and medical devices. FDA regulation of these products involves both premarket and postmarket regulatory requirements. The four user fee programs discussed in this report are prescription drugs, medical devices, generic drugs, and biosimilars. The Prescription Drug User Fee Act of 1992 (PDUFA, P.L. 102-571); The Medical Device User Fee and Modernization Act of 2002 (MDUFMA, P.L. 107-250) or MDUFA; The Generic Drug User Fee Amendments of 2012 (GDUFA, Title III of FDASIA, P.L. 112-144); The Biosimilar User Fee Act of 2012 (BsUFA, Title IV of the Food and Drug Administration Safety and Innovation Act [FDASIA], P.L. 112-144). Center for Biologics Evaluation and Research (CBER) regulates traditional biologics, such as vaccines. Center for Devices and Radiological Health (CDRH) regulates medical devices. Center for Drug Evaluation and Research (CDER) regulates prescription brand-name and generic drugs, over-the-counter drugs, and most therapeutic biologics.