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Immediate-Release Opioids Now Under REMS

Source: FDA

The FDA has broadened its Risk Evaluation and Mitigation Strategy (REMS) to include immediate-release opioid analgesics as well as the extended-release, long-acting agents previously covered. AAPM has provided ongoing input to the FDA at each stage of this REMS development and was an active advocate for extending the program to include immediate-release.
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