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Evans M et al. – Earlier this year, the U.S. Food and Drug Administration (FDA) announced its intent to require manufacturers of two dozen opioid formulations to construct detailed Risk Evaluation and Mitigation Strategies (REMS) for their products in order to verify that their benefits to pain management continue to outweigh the potential risks associated with abuse and misuse. In addition to individualized REMS for certain branded and generic drugs, the FDA also plans to issue a formal REMS for the opioid drug class as a whole, which may take up to a year to develop.

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