US FDA Advisory Panel Split On Value Of Education In Fentanyl REMS
Some members feel more education has important role in risk management for transmucosal immediate-release fentanyl products, while others think further education will be useless in ensuring the REMS meets its goals.
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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.
Subsys Makes A Bad Impression On FDA REMS Panel Members
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Off-Label Use Of Transmucosal Fentanyl Creates Ethical, Practical Dilemma For US FDA
Advisory committee panelists divided on whether to modify REMS for TIRF products to reduce their wide-ranging off-label use.