FDA Panel To Consider Strategies For Timely Completion Of Accelerated Approval Confirmatory Trials

 
• By Sue Sutter

Confirmatory trials for anti-cancer drugs should be targeted for completion no later than two to four years after accelerated approval is granted, agency says, offering various strategies and factors sponsors should consider to ensure they are conducting studies with due diligence.

Hammer
FDA may be more willing to bring down the hammer on oncology accelerated approval drug sponsors who fail to conduct their confirmatory trials with due diligence. • Source: Shutterstock

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