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FDA Expanding Opioid REMS To Immediate Release Formulations

 
• By Brenda Sandburg

Commissioner Gottlieb tells opioid scientific workshop that updated REMS will also require training to be available to nurses and pharmacists; agency beginning new study on prescriber perceptions.

Opioid abuse epidemic concept

In an appearance emphasizing the importance of opioid policy at FDA, Commissioner Scott Gottlieb announced during a scientific workshop that the agency is updating the current Risk Evaluation and Mitigation Strategy (REMS) for extended release and long-acting (ER/LA) opioids to include immediate release opioids.

Gottlieb told experts attending the July 10 meeting that letters detailing the new requirements will be sent to immediate release manufacturers in the coming weeks.

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