Columbia/Watson’s Progesterone Gel For Preterm Births Needs Additional Studies, Advisory Panel Says
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s Reproductive Health Drugs Advisory Committee recommended against approving the drug in twin 13-4 votes due to concerns about inconsistent foreign data. If the sponsors move forward with another trial, they may have to use a comparative, rather than placebo-controlled, design.
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