REMS Standardization Could Help Opioid Education Efforts
FDA hopes to begin accepting Risk Evaluation and Mitigation Strategy documents in structured product labeling format later this year.
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The recent US advisory committee review of the Transmucosal Immediate-Release Fentanyl REMS program is important as another marker of the fraught climate around prescription opioid abuse. But it may have broader implications for the future of drug safety regulation and the REMS model.
FDA advisory committee's preferred approaches – linking mandatory training to DEA registration or state medical board licensing – are outside agency's existing regulatory authority.
There is concern that common software package could mean more drugs end up with risk management programs.