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REMS
CME Programs to Reduce Opioid Abuse
Over the past several years, there has been significant attention drawn the prescription drug abuse and overuse of painkillers or…
ER-LA Opioid REMS CME Critics and the ACCME’s Vigorous Response
Although many praised the Food and Drug Administration (FDA) for releasing its long-awaited Risk Evaluation and Mitigation…
FDA REMS: Mycophenolate Class Wide REMS
Over the past few months, we have seen increased activity at the Food and Drug Administration (FDA) with respect to the issuance…
The Joint Commission Provides Hospitals Guidance for Better Opioid Use…
Over the past few years, there has been a growing focus on the abuse, misuse, and overuse of opioids or painkillers. Public…
FDA Releases Final Risk Evaluation and Mitigation Strategies (REMS) for…
After three years of work the Food and Drug Administration (FDA) released its final Risk Evaluation and Mitigation Strategies…
FDA REMS to Promote Closer Ties to Healthcare Professionals
A recent article from the Food Drug Law Institute (FDLI) Update Magazine, discussed a recent session entitled “The Impact of…
FDA REMS: Blue Print for Prescriber Continuing Education Program for…
The Food and Drug Administration (FDA) released a “Blueprint for Prescriber Continuing Education Program” regarding the use of…
Physician Payment Sunshine: French Parliament Takes Up Industry Physician…
As part of a draft bill reforming the drugs approval and safety system, France may soon require that conflicts of interests…
FDA Opioid REMS: White House Proposes Mandated Certified CME
This past week, the White House “unveiled a multi-agency plan aimed at reducing the “epidemic” of prescription drug abuse in the…
Risk Evaluation and Mitigation Strategies (REMS) Summary
According to a recent assessment by the Tufts Center for the Study of Drug Development (CSDD), “drug developers, healthcare…