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Surprisingly, Fewer 'Expedited' New Drug Approvals In 2015

This article was originally published in Scrip

Executive Summary

Even though the FDA's Richard Pazdur and his Office of Hematology and Oncology Products appeared to be on fire in 2015 – approving many medicines well ahead of their Prescription Drug User Fee Act (PDUFA) action date – there were fewer applications for novel drugs and biologics overall cleared for marketing under the agency's expedited pathways than a year earlier.

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