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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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Columbia’s Progesterone Faces FDA Skepticism Over Foreign Data At Advisory Committee


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