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Accelerated Approval: US FDA Explains When A Confirmatory Trial Is ‘Underway’

 
• By Sue Sutter

The agency will consider study enrollment, accrual rates and the number of clinical site activations, among other factors, in determining whether a confirmatory trial is underway prior to accelerated approval, but the new draft guidance does not specify the proportion of patients that must be enrolled at the time of approval.

Cruise ship
It may not be as obvious as a cruise ship when a confirmatory trial gets underway. (Shutterstock)

The US Food and Drug Administration will consider study enrollment, accrual rates and clinical site activations, among other factors, in determining whether a confirmatory trial is sufficiently underway and available for accelerated approval.

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