Generic Drugs: First-Cycle Review Times Improve, But Hundreds Of ANDAs Still Pending
US FDA cut first-cycle review time 46% between fiscal year 2013 and FY 2015, but more than 900 ANDAs still awaited review by end of 2016.
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Prioritizing ANDAs entering markets with fewer than three approved generics not expected to become a major advantage until first-cycle clearances increase.
US FDA has historically overestimated generic review performance in budget requests, but recently underestimated the number of ANDAs it expects to approve.
Pre-launch communication from agency would allow sponsors to ramp up commercial activities and could head off some innovator company legal challenges to ANDA approvals, attorneys say; CDER’s Moscicki suggests GDUFA goal dates now provide sponsors some level of predictability.