In July, FDA Commissioner Scott Gottlieb, MD, put the public and manufacturers on notice that the agency would soon require the IR opioid analgesics that are intended to be used in the outpatient setting to be subject to the same REMS requirements as the ER/LA opioid analgesics. On September 28, Dr. Gottlieb said the agency had now taken action and that 277 IR opioids would be subject to Risk Evaluation and Mitigation Strategy (REMS) requirements.

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