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When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval

 
• By Bridget Silverman

More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.

Breakthrough designations have allowed many therapies to climb quickly through development and review, but more are falling short of approval and getting complete response letters. • Source: Alamy

Complete response letters are becoming a more likely outcome for applications with the FDA’s marquee expedited review status, an analysis using the Pink Sheet’s US FDA Performance Tracker shows.

Products bearing a breakthrough therapy designation have a history of success when it comes time for the FDA to decide on approvability. Nine out of 10 FDA decisions on applications...

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