'False hopes': FDA releases briefing docs on controversial preterm birth med Makena ahead of adcomm
The FDA’s Center for Drug Evaluation and Research (CDER) dropped its briefing documents spelling out why Covis’ controversial preterm birth drug Makena should be pulled from the market — and it isn’t mincing words.
Ahead of an advisory committee meeting scheduled for Oct. 17-19, CDER released an 86-page briefing on Makena, which was approved in 2011 through the FDA’s accelerated approval pathway.
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