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Diane Publishing Books
Food & Drug Administration: Effect of User Fees on Drug Approval Times, Withdrawals, & Other Agency Activities
Janet Heinrich (au). In 1992, the Prescription Drug User Fee Act (PDUFA) was enacted to provide additional resources for the FDA to speed up the process of reviewing applications for new drugs & biological products. This report examines: (1) how PDUFA has affected the funding & approval times for FDA’s review of new drug & biologic applications, (2) whether PDUFA has had an effect on the funding & oper. of FDA’s non-PDUFA activities, (3) whether the workload, attrition, & non-professional development of FDA reviewers have changed since the user fee program was reauthorized in 1997, & (4) how the rate of drug withdrawals from the market has changed since PDUFA was enacted in 1992 & what actions are being taken by FDA to monitor adverse drug effects. Charts & tables.
Lamborghini: Supercar Supreme
Country Ribbon Crafts: Delightful Projects Using Easy Techniques
Air Combat: The New Face of War
Live Now, Age Later: Proven Ways to Slow Down the Clock
War of the Rebellion: Official Records of the Union & Confederate Armies: Series I, Volume I
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