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

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