Association between pre-approval confirmatory trial initiation and conversion to traditional approval or withdrawal in the FDA accelerated approval pathway


27 January 2023 - The accelerated approval pathway allows the US FDA to approve drugs that demonstrate an effect on a surrogate outcome that is reasonably likely to predict clinical benefit. 

Following accelerated approval, manufacturers are required to verify clinical benefit in confirmatory trials.

Delays in confirmatory trial completion have led to proposals for reforming the accelerated approval pathway. One proposal would require a confirmatory trial initiation prior to accelerated approval.

Read JAMA article

Michael Wonder

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Michael Wonder