REMS Assessments For Opioids Will Require Data From Across Health System
Executive Summary
Measuring success will be one of the thorniest issues confronting sponsors as they implement the FDA-mandated Risk Evaluation and Mitigation Strategy for long-acting/extended-release opioids.
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Opioid Class-Wide REMS May Launch Without Element To Monitor Prescribing
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Opioid Class-Wide REMS May Launch Without Element To Monitor Prescribing
All metrics for assessing the effectiveness of the Risk Evaluation and Mitigation Strategy for long-acting/extended release opioids may not be in place when FDA approves REMS for individual products.