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Accelerated Approval Under Review By US FDA: Completing Confirmatory Trials A Focus

 
• By Kate Rawson

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.’

Gears (Jakub Janele/Shutterstock.com)

The US Food & Drug Administration is taking a hard look at the Accelerated Approval pathway with an emphasis on how to better ensure that confirmatory trials are completed in a timely manner and that products that do not meet the evidentiary standard are quickly removed from the market.

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