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

Executive Summary

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.

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Makena Accelerated Approval Withdrawal Hearing Should Be In-Person, Covis Tells US FDA

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US Accelerated Approval: As Makena Withdrawal Hearing Looms, A Look Back At The Avastin Experience

With the public hearing on Covis’ drug for preterm birth prevention expected in 2022, the Pink Sheet talked to several former FDA officials and advisory committee members about their experiences at the 2011 hearing on withdrawal of Avastin’s accelerated approval for breast cancer.

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