Opioid REMS: New CME 'Blueprint' To Include Immediate-Release Drugs
US FDA is moving forward on two fronts to update and improve the Risk Evaluation & Mitigation Strategy to help limit misuse and abuse of opioid pain medications: the agency has a plan to incorporate IR sponsors into the existing REMS, and also a new 'blueprint' for the prescriber education that focuses on pain management.
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Opioid REMS Revisions Reflect Some, Not All, Stakeholder Concerns
US FDA's education blueprint now asks sponsors to extend REMS to health providers beyond prescriber, but pain classifications remain unchanged.
Opioid Litigation: Court Asks US FDA To Attend Education Session
Judge overseeing multidistrict litigation convenes meeting with senior pharma executives, government plaintiffs and others to learn about supply-chain dynamics and other issues to resolve more than 200 suits.
FDA Expands Opioid Abuse Research, Outreach
US agency signs contracts for more real-world data on abuse; officials also meet with AMA representatives to discuss opioid prescriber education.