FDA NME APPROVAL TIME FOR RECENT SUBMISSIONS AVERAGING 12.3 MONTHS
FDA NME APPROVAL TIME FOR RECENT SUBMISSIONS AVERAGING 12.3 MONTHS, Center for Drug Evaluation & Research Deputy Director Murray Lumpkin, MD, reported at a Sept. 21 meeting of a PDA/FDA joint conference in Bethesda, Md. FDA has approved 12 new molecular entities in calendar 1994. Seven of the NMEs were filed in FY 1993 after the agency began collecting user fees, Lumpkin reported. Those seven applications received approval in an average of 12.3 months, substantially lower than the average review time of 26.5 months for all NMEs approved in 1993.
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