Accelerated Approval Under Review By US FDA: Completing Confirmatory Trials A Focus
Top officials want confirmatory trials to finish in a ‘reasonable amount of time’ and worry that ‘if 100% of them were able to confirm, then the bar’s too high.’
Top officials want confirmatory trials to finish in a ‘reasonable amount of time’ and worry that ‘if 100% of them were able to confirm, then the bar’s too high.’