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PDUFA Performance In The FDAAA Era: Over One Third Of Novel 2009 CDER Approvals Took Advantage Of Relaxed User Fee Goal Interregnum

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

CDER met the user fee goals of almost two-thirds of new molecular entities and novel therapeutic biologics approved in 2009, even at the height of the almost two-year period when Office of New Drugs Director John Jenkins allowed reviewers to miss Prescription Drug User Fee Act action dates due to workload and resource constraints

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