Makena Follows Avastin’s Path With US FDA Hearing On Accelerated Approval Withdrawal

 
• By Sue Sutter

Chief scientist Denise Hinton will decide the fate of Covis’ preterm birth prevention drug because acting commissioner Janet Woodcock has recused herself; CBER deputy director Celia Witten is tapped to serve as presiding officer at the hearing, which will be only the second of its kind under accelerated approval regulations.

Footsteps in sand
Covis is following Genentech's footsteps on a route that will take the Makena sponsor to a public hearing under the accelerated approval regulations. • Source: Alamy

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