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US FDA Still Hasn’t Decided Who Will Be Final Arbiter On Approval Status For Covis’ Makena

 
• By Sue Sutter

With two weeks to go before hearing on whether the preterm birth prevention drug can stay on the market or be withdrawn, the lack of clarity on who will make the ultimate decision may stem from the lengthy duration of the dispute and multiple transitions within FDA’s senior leadership.

Decider
Who will be 'The Decider' on Makena? We still don't know. • Source: Shutterstock

With just two weeks until the public hearing on the proposed withdrawal of accelerated approval for Covis Pharma's Makena (hydroxyprogesterone caproate), the US Food and Drug Administration still has not determined who will make the final decision on the fate of the preterm birth prevention drug.

Center for Biologics Evaluation and Research Deputy Director Celia Witten will serve as presiding officer at the 17-19 October public hearing

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