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

CRS Report for CongressPrepared for Members and Committees of Congress How FDA Approves Drugs and Regulates Their Safety and Effectiveness Susan Thaul Specialist in drug Safety and Effectiveness June 25, 2012 Congressional Research Service 7-5700 R41983 How FDA Approves Drugs and Regulates Their Safety and Effectiveness Congressional Research Service Summary Update: On June 20, 2012, the House of Representatives passed, by voice vote and under suspension of the rules, S. 3187 (EAH), the Food and drug Administration Safety and Innovation Act, as amended.

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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