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.
Accelerated Approval: US FDA Explains When A Confirmatory Trial Is ‘Underway’
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among other factors, in determining whether a confirmatory trial is underway prior to accelerated approval, but the new draft guidance does not specify the proportion of patients that must be enrolled at the time of approval.
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