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: Food and Drug Administration
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 […]