Drug and biologic product sponsors should anticipate that US Food and Drug Administration review divisions will become more insistent in 2023, though perhaps not absolute, about the need for confirmatory trials to be underway at the time a product receives accelerated approval.
A Greater Power: US FDA May Become More Insistent On Timing Of Accelerated Approval Confirmatory Trials
Bolstered by new statutory authority and the Oncology Center of Excellence’s experience in pushing for early initiation of confirmatory trials, review divisions may take a tougher line with sponsors on the design and timing of studies to verify clinical benefit.