Shared REMS For Transmucosal Fentanyls Could Expand Market For Meda’s Onsolis As It Exits More Restrictive Program
By
Cathy Dombrowski / Email the Author / Pharmaceutical Approvals Monthly January 2012, Vol. 17, No. 1
FDA Policy / Word Count: 456 / Article # 06120101010
Executive Summary
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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