‘Industry Failing On Evidence Generation,’ US FDA’s Califf Says Of Accelerated Approvals

 
• By Francesca Bruce

As a “laborious” hearing at the Food & Drug Administration on whether to withdraw the accelerated approval for Covis’s pre-term delivery drug Makena, FDA chief Robert Califf commented that industry is not doing enough to provide the evidence required for the fast-track approval pathway.

FDA Commissioner Robert Califf testifies at House Appropriations Committee hearing
Reform of the accelerated approval pathway will be “considered later this year in one way or another," said FDA chief Califf • Source: Screenshot

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