Food & Drug Administration: Effect of User Fees on Drug Approval Times, Withdrawals, & Other Agency Activities

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Our Price: $15.00

Year: 2002
Pages: 51
Binding Paperback

Product Code: 0756742897

Description

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.

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