Abstral REMS Sets Stage For Risk Reduction Plans For Similar Fentanyls
FDA's decision to create a class Risk Evaluation and Mitigation Strategy for all transmucosal fentanyl products indicates that the agency could take a similar strategy with the extended-release opioids.
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Common registration site for participants in REMS was endorsed by several panel members during a joint meeting of the Drug Safety and Risk Management and Dermatologic and Ophthalmic Drugs Advisory Committees.
"REMS-related topics" is the theme of a joint FDA advisory committee meeting Dec. 1 focused on the landmark iPLEDGE program as an example of the effect such programs have on the health care system.
Final guidance softens a recommendation that manufacturers of transdermal and transmucosal drug delivery systems and topical patches use a Quality by Design approach.