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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.

That sentiment, while brewing for some time, was confirmed by top drug officials during Prevision Policy/Friends of Cancer Research’s Biopharma...

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