Posted by Michael Wonder on 08 Mar 2025
FDA’s accelerated approval guidance gets pushback from industry
7 March 2025 - The pharmaceutical industry has some questions regarding the US FDA's recent guidance on its accelerated approval program for drugs and biologics.
Industry groups also asked for greater clarity about when the agency will provide feedback on confirmatory trials and how the guidance would align with the agency’s other policies on accelerated approval.
In addition, PhRMA questioned the need of confirmatory studies for certain treatments granted accelerated approval, especially for programs that address unmet medical needs. The group argued that Congress did not intend to mandate confirmatory trials for all drugs that receive accelerated approval.
