FDA Releases Draft Opioid REMS Prescriber Education Blueprint; Open for Comment November 8, 2011 News FDA, opioid REMS 0 The Food and Drug Administration (FDA) has published a draft outline for physician educational programs as part of the opioid risk evaluation and mitigation strategy (REMS). The 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. The 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. The draft will only be open for comment for 30 days, until December 7, 2011. Please click here to review the draft. Comments may be submitted in two ways: Electronically through http://www.regulations.gov Via postal mail to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 Comments are closed.
