New Drugs In 2013 Show A Virtuous Cycle: First-Cycle Approvals Up, Review Times Down
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Even with half of CDER’s approvals qualifying for longer review timeframes under “the program,” the average time from submission to approval continued its multi-year decline, helped by a record high level of first-cycle approvals. Small molecules and big pharma dominated the 2013 class.