Information by Drug Class > Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS)

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled “Blueprint for Prescriber Education for the Long-Acting/Extended-Release Opioid Class-wide REMS” (Blueprint). The draft Blueprint 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 required risk evaluation and mitigation strategy (REMS) for these products (Opioid REMS). FDA seeks stakeholder input on the document. After comments are received, FDA will revise the Blueprint as appropriate, incorporate it into the Opioid REMS when it is approved, and post it on FDA’s Web site for use by CE providers. To view the Federal Register Notice, please visit: Draft Blueprint:
http://www.ofr.gov/OFRUpload/OFRData/2011-28669_PI.pdf

For more information please visit: Opioid REMS:
Information by Drug Class > Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS)