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A Look At The First Six Shared REMS

Executive Summary

The multi-sponsor shared Risk Evaluation and Mitigation Strategies approved to date vary greatly in size, ranging from two to 21 sponsor participants.

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Shared REMS Systems Show Challenges Of Standardization – Could PDUFA V Help?

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.

Shared REMS Systems Show Challenges Of Standardization – Could PDUFA V Help?

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.

Buprenorphine Waiver Sheds Little Light On FDA Decision-Making Process

But the agency appeared willing to consider a waiver because the innovator and generic sponsors could not reach agreement on a shared REMS.

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