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U.S. Department of Health and Human Services

Drugs

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March 3, 2009 Industry Meeting on Risk Evaluation and Mitigation Strategy (REMS) for Certain Opioid Drugs

FDA recognizes that putting together a workable REMS for these widely prescribed opioid products will present challenges. Therefore, we decided to invite all affected sponsors to a meeting to discuss how such a program can best be designed to manage the risks while also considering reasonable burdens to the health care system. This meeting was held on March 3, 2009. FDA presented a high-level overview, regulatory background, and the proposed elements of the REMS followed by questions and comments from the sponsors.

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