If the 7 September Amylyx Pharmaceuticals, Inc. ALS advisory committee was the day that the US Food and Drug Administration put out the regulatory flexibility welcome mat, ushering sponsors to walk in, then Makena’s 17-19 October withdrawal hearing was the day it slammed the door in industry’s face.
FDA may have a legal obligation to exercise regulatory flexibility, but that flexibility is not infinite, and the Center for Drug Evaluation and Research used the three-day hearing on its proposal to withdraw Covis Pharma’s preterm birth
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