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

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