The US Food and Drug Administration (FDA) on Thursday issued draft guidance that would replace the accelerated approval portion of its broader guidance covering its various expedited pathways to reflect changes to the accelerated approval program brought on by recent legislation.
Under the Consolidated Appropriations Act of 2023 (CAA), Congress mandated changes to the program, giving FDA new authorities for setting conditions for confirmatory trials and establishing new procedures for withdrawing products if they fail to demonstrate clinical benefit.
“This draft guidance addresses the accelerated approval process, including granting accelerated approval (e.g., discussion of endpoints, evidentiary criteria, confirmatory trials and other conditions of accelerated approval), and withdrawal of accelerated approval,” said FDA. “Changes from the 2014 final guidance include early consultation on novel endpoints, timely conduct of confirmatory trials, other aspects of confirmatory trials, and the expedited withdrawal of accelerated approval.” …
