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

Executive Summary

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 Opposes Covis’ Bid To Steer Focus Away From Makena's Failed Confirmatory Trial

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