FDA One Step Closer To Makena Withdrawal After Hearing Officer Echoes Advisory Panel’s Advice

In a memo to Commissioner Califf and Chief Scientist Bumpus, Celia Witten focuses the final Makena decisionmakers on the key factors she believes should be used to determine the drug’s market status.

dominoes falling
Revocation of Makena’s Accelerated Approval Looks Increasingly Likely • Source: Shutterstock

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