REMS Explanation

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The FDA has reopened the Federal Register for comments on the Risk Evaluation and Mitigation Strategies, or REMS, for certain opioid drug products. The new deadline for comments is October 19, 2010 which indicates that no action will be taken for at least a year. The move shows that the agency recognizes the problems identified in the comments filed about the development of an opioid REMS, which has important implications for the daily practice of clinicians, and the need to ensure a REMS does not unduly burden the health care system or limit patient access. We will monitor this development and keep you posted as needed.