On December 5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: Accelerated Approval of Drugs and Biologics Guidance for Industry” (the “Draft Guidance”).[1] FDA’s so-called “accelerated approval” program is designed to expedite the development and review of new drugs and/or biologics that fulfill unmet medical needs for serious or life-threatening conditions by granting market approval to therapeutics that show promise by meeting a surrogate endpoint (so long as the drug and/or biologic sponsor promises to conduct post-market, confirmatory trials to verify safety and efficacy). The Draft Guidance updates FDA’s policies and procedures for accelerated approval, including heightened requirements for confirmatory trials and a new process for expedited withdrawal of approval, based on mandates from the 2023 Consolidated Appropriations Act, which was penned to address concerns over the lag time between initial approvals under the accelerated approval program and final approval following the successful completion of confirmatory trials.[2] FDA is inviting comments to the Draft Guidance, with a deadline set for February 2, 2025.Continue Reading New Accelerated Approval Guidance Underscores Need for Accountability