Everything REMS Under The Sun: FDA Lays Out Ambitious PDUFA V Meeting Agenda
This article was originally published in The Pink Sheet Daily
The struggles that industry and FDA face when trying to best standardize and evaluate REMS are illustrated by the dozens of topics jammed into the two-day meeting.
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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.
Hurdles to developing multi-sponsor programs include disagreements on design, decision-making and cost-sharing. PDUFA V initiatives on standardizing and integrating REMS could give FDA a means for providing more formal guidance or rulemaking on developing shared systems, as some in industry have requested.
FDA’s Drug Safety and Risk Management Advisory Committee endorses replacing paper-based verification system for the irritable bowel syndrome drug with an electronically integrated process that the agency seems to favor; the electronic system currently is used in the REMS for transmucosal immediate-release fentanyl products.