US FDA May Become More Insistent On Timing Of Accelerated Approval Confirmatory Trials

By Sue Sutter

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.

The agency’s new authority under the Food and Drug Omnibus Reform Act to require that studies be started prior to approval, or within some specified period of time, thereafter, may embolden reviewers to take a harder stand with sponsors when it comes to confirmatory trial planning and initiation, although much will depend on the product itself and the therapeutic setting, experts said.

Learn more about these possible changes sponsors may experience when compiling study designs and timelines to verify clinical benefit.