Shared REMS For Transmucosal Fentanyls Could Expand Market For Meda’s Onsolis As It Exits More Restrictive Program
This article was originally published in The Pink Sheet Daily
Class-wide Risk Evaluation and Mitigation Strategy for transmucosal immediate-release fentanyl products will begin operations in March 2012, with participants in REMS for individual products to be transitioned automatically to the new system.
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Commissioner Robert Califf said the new plan should be released in August and include prongs to continue fighting the ongoing prescription opioid epidemic, as well as confront a new synthetic fentanyl and methamphetamine problem.
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Participants in a two-day FDA meeting on REMS standardization and assessment suggested a website containing all REMS information and enrollment functions and allowing interaction with existing health records and claims systems would facilitate compliance with safety requirements.