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Makena Withdrawal Hearing: US FDA Drugs Center, Covis Tussle Over Panel Composition

 
• By Sue Sutter

Practicing obstetricians who are maternal fetal-medicine specialists should make up a ‘significant proportion’ of the advisory committee at the forthcoming hearing, Covis says; CDER calls for a more ‘balanced’ panel that includes expertise in biostatistics, neonatology and epidemiology.

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CDER and Covis disagree on the expertise needed for the Makena public hearing panel and on disclosure issues. • Source: Alamy

Covis Pharma and the US Food and Drug Administration’s drugs center and are staking out different positions on the types of expertise needed on the advisory committee that will serve as the figurative “jury” at a forthcoming public hearing on possible withdrawal of accelerated approval for the preterm birth prevention drug Makena.

Covis asserts a “significant proportion” of the advisory committee should comprise practicing obstetricians who are maternal fetal-medicine (MFM) specialists, including physicians with

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