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A Greater Power: US FDA May Become More Insistent On Timing Of Accelerated Approval Confirmatory Trials

 
• By Sue Sutter

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.

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Timely initiation of clinical trials is likely to become an increasing focus for the FDA. • Source: Shutterstock

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

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