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.
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FDA announces the October meeting unusually early following legislative efforts to further restrict access to the opioid pain reliever due to abuse worries.
FDA and other federal agencies could better coordinate their efforts to educate prescribers about prescription pain reliever abuse, the Government Accountability Office said.
“We don’t really have clear methods for assessing burden and access,” CDER’s Mary Willy acknowledges. A lack of baseline information hinders the measurement of whether REMS and their components are working.