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Fewer 'Expedited' New Drug Approvals In US In 2015

This article was originally published in SRA

Executive Summary

Even though the US Food and Drug Administration's Office of Hematology and Oncology Products approved many medicines well ahead of their Prescription Drug User Fee Act action date in 2015, there were fewer applications for novel drugs and biologics overall cleared for marketing under the agency's expedited pathways than a year earlier.