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

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...

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