The Food and Drug Administration today released draft guidance for assessing risk evaluation and mitigation strategies. FDA may require a REMS before approving certain drugs, including biologics, to help ensure its benefits outweigh its risks. FDA Commissioner Scott Gottlieb, M.D., said the guidance provides a framework for companies to develop an assessment plan when they develop a REMS program to improve the quality of the information used to assess the program’s effectiveness and provide post-market evidence that the REMS is meeting its risk mitigation goals. “We need to make sure that the REMS are achieving their public health goals, and that we’re designing and implementing these approaches in ways that minimize burdens to patients and providers,” he said.

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