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Battle over pregnancy drug highlights risks of FDA expediting drugs to market

Por: Politico Health October 16, 2022

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The FDA will make its case this week to do something it hasn’t in over a decade — order a drug it expedited to the market to be pulled. A panel of independent expert advisers on obstetric and reproductive drugs will meet starting Monday to decide whether to recommend that Makena, an injection marketed as lowering the risk of preterm birth, remain available for at least some patients. The years-long effort to yank the drug’s approval offers... + full article



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