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Makena Accelerated Approval Hearing Will Be Virtual, Likely In September Or October

 
• By Sue Sutter

Presiding officer Celia Witten denies Covis’ request for an in-person hearing, saying it is unclear at this time how COVID would affect a proceeding in the fall. Hearing agenda spans two-and-a-half days and is modeled, in part, on the Avastin hearing, but with twice the time for public comment.

Calendar
The Makena hearing is expected to take place over two-and-a-half days in the fall. • Source: Alamy

The US Food and Drug Administration hearing on a proposal to withdraw accelerated approval of Covis Pharma’s preterm birth prevention drug Makena (hydroxyprogesterone caproate) will likely take place in September or October and will be conducted virtually.

In a 21 April letter, hearing officer Celia Witten denied Covis’ request that the hearing be conducted in-person or, alternatively, in a hybrid format

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