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‘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

The pharmaceutical industry is failing to produce the necessary follow-up studies to maintain accelerated approvals, US Food & Drug Administration Commissioner Robert Califf said at a regulatory affairs conference this week. His comments came as an FDA hearing is underway to determine whether the agency’s accelerated approval for Covis Pharma’s Makena (hydroxyprogesterone caproate or 17-OHPC) should be withdrawn.

Califf has previously said that the main way to improve the accelerated approval pathway is to cut the time between approval and the final determination of the clinical risk and benefit

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