FDA Gene Therapy Office Chief Prefers Flexibility With Accelerated Approval Confirmatory Trials

Ideally, the studies would be underway at the time of approval, as the US FDA’s new authority allows, but Office of Therapeutic Products Director Nicole Verdun sys there will be exceptions.

Nicole Verdun at 2023 ASGCT Policy Summit — Nicole Verdun (left) discussed accelerated approval and other cell and gene therapy issues during the ASGCT Policy Summit. • Source: Screenshot of conference livestream

Confirmatory study timing for cell and gene therapies gaining accelerated approval is not going to be mandated, new Office of Therapeutic Products Director Nicole Verdun said.

Verdun prefers that confirmatory trials be underway at the time of approval, but acknowledged there will be exceptions.