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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.

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Japan Looks To Build Domestic Capacity In New Modalities

 
• By Lisa Takagi

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GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

 
• By Cathy Kelly

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• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.