Stairway To Heaven: REMS Website Integrated With Health Care Systems
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.
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“Before we can standardize REMS we need to have that common language to describe what’s in the REMS,” FDA’s Adam Kroetsch says.
Shared REMS For Transmucosal Fentanyls Could Expand Market For Meda’s Onsolis As It Exits More Restrictive Program
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.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.