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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...

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