Three Overhauls to Accelerated Drug Approval You Need to Know About: Novel Endpoints, Confirmatory Trials, and Expedited Withdrawal of Approvals
By EsqSocial Corporation 19/12/24
Earlier this month, the US Food and Drug Administration (FDA) issued new draft guidance regarding their accelerated approval pathway for new drugs and biologics, an expedited program designed to help address unmet medical needs for serious or life-threatening conditions. As usual, the FDA is soliciting comments to the new guidance, due by February 4, 2025....
By: ArentFox Schiff