Public Comment Period Opens for Draft Opioid REMS Prescriber Education Program

On November 7, 2011, the US Food and Drug Administration (FDA) published in the Federal Register a draft outline (Blueprint) for physician educational programs as part of the Opioid Risk Evaluation and Mitigation Strategy (REMS). The FDA seeks stakeholder input on the Blueprint, which will be open for public comment until December 7, 2011.

Click here to read “Blueprint for Prescriber Education for the Long-Acting/Extended-Release Opioid Class-wide REMS.” The draft contains core messages intended for use by continuing education (CE) providers to develop educational materials to train prescribers of long-acting and extended-release opioids under the REMS requirements for these products.

See also FDA Opioid REMS webpage: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm.

 
 

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