After three years of work the Food and Drug Administration (FDA) released its final Risk Evaluation and Mitigation Strategies (REMS) for extend-release (ER) and long-acting (LA) opioid medications. This is the first time that the FDA has mandated a class wide REMS and much of what is recommended will be looked at closely for future […]
Tag Archives: REMS
CME, FDA, REMS
FDA REMS: Blue Print for Prescriber Continuing Education Program for Extended Release-Long Acting Opioids
08
Nov
Nov
The Food and Drug Administration (FDA) released a “Blueprint for Prescriber Continuing Education Program” regarding the use of opioids. 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 […]
13
Aug
Aug
The Accreditation Council of Continuing Medical Education (ACCME) announced a number of important topics in their recent August newsletter, including an executive summary of its Board of Directors meeting, a summary of ACCME revisions to the Complaints Process, and an explanation of ACCME affirming knowledge-based activities in CME. The ACCME Board of Directors meeting, which […]
04
Aug
Aug
During last month’s Joint Meeting of the Anesthetic and Life Drugs Advisory Committee (ALSDAC) & Drug Safety and Risk Management Advisory Committee (DSaRM), the Accreditation Council for Pharmacy Education (ACPE) delivered comments regarding Risk Evaluation and Mitigation Strategies (REMS) for extended-release and long-acting opioid analgesics. The presentation, which was delivered by ACPE Executive Director Peter […]
08
Jul
Jul
According to a FDA memo and recent article in the RPM Report, “continuing medical education (CME) has been under attack in Washington in recent years, criticized as representing a way around FDA’s control of medical promotion.” This trend however, is beginning to change. The Food and Drug Administration’s (FDA) is now “turning back to CME […]