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Califf Says Accelerated Approval A ‘Different Objective’ And ‘Lower Hurdle’

 
• By Derrick Gingery

The US FDA's comment came in response to a question about whether accelerated approval encourages sponsors to conduct lower-quality studies to enter the market.

FDA Commissioner Robert Califf spoke extensively about accelerated approval and areas for reform on 31 March. • Source: Alamy

FDA Commissioner Robert Califf said using the accelerated approval pathway does not indicate the development program is inferior to one seeking a regular clearance, but also suggested the unvalidated surrogate used with the expedited pathway was a “lower hurdle.”

During the 31 March Stat Breakthrough Science Summit, Califf said accelerated approval was intended to defer information on clinical outcomes until later

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