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9780756742898
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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.Heinrich, Janet is the author of 'Food And Drug Administration Effect of User Fees on Drug Approval Times, Withdrawals, And Other Agency Activities', published 2002 under ISBN 9780756742898 and ISBN 0756742897.
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