Anything Worth Doing Is Worth Doing Right: FDA Issues Draft Guidance on Requirements and Processes for Accelerated Approval
By EsqSocial Corporation 20/12/24
On December 5, 2024, the U.S. Food and Drug Administration (“FDA”) issued a much anticipated draft guidance for industry on accelerated approval that provides additional clarity on FDA’s expectations for accelerated approval endpoints and confirmatory trials as well as FDA’s process for withdrawing accelerated approval (the “Draft Guidance”). As part of the Food and Drug Omnibus Reform Act (“FDORA”), which was passed in late 2022, Congress had required FDA to issue guidance on various topics...
By: Ropes & Gray LLP