How FDA Approves Drugs and Regulates Their Safety and ...

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May 08, 2018 · 7 CRS Report R44864, Prescription Drug User Fee Act (PDUFA): 2017 Reauthorization as PDUFA VI. 8 The prescription drug and generic drug user fees were most recently reauthorized by the FDA Reauthorization Act of 2017 (FDARA; P.L. 115-52). See CRS Report R44703, Generic Drugs and GDUFA Reauthorization: In Brief, and CRS Report R44961, . ; CRS ; .

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