Subsys Makes A Bad Impression On FDA REMS Panel Members
CMS and FDA data showed prescriptions jumping while other fentanyl products were coming down.
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TIRF REMS Debate: Advisory Committee Chair Speaks Out
University of Kentucky anesthesiologist Raeford Brown says problem with transmucosal fentanyl regulation isn’t the REMS – it's that the products are approved at all.
Asleep At The Switch? FDA’s TIRF REMS May Not Be A Model After All
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.
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.