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Impact of Prescription Drug User Fee Program Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research September IS,2000 Overall Assessment Program has been successful achieving its original goals: l l l in Eliminate backlogs Decrease review times Shorten time to approval 3 . -- PDWFA Benefits: access Public l Faster to new therapies l Increased industry incentive to invest in new therapeutic areas . l Greater l Improved openness of the process drug development , PDUFA l Benefits: Regulation Improved l l l resources More reviewers, pm-approval computer statt Upgraded Infrastructure Highly-skilled new staff l Better industry l Streamlined PDUFA l l I FDA Drug Greater Access input inspectors, applications processes Benefits: openness to Agency advice & --. -e-- I Challenges l Covers limited part of drug life cycle premarket review - does not support: l l l _. -..e .- I - Drug safety surveillance after approval Drug advertising regulation . GMP surveillance l Limits l of PDUFA , Tracking FDA flexibility subsidiary to manage resources goals is burdensome . 2