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Drug Safety: FDA Pushes To Publicly Release REMS Assessments, Says It Will Improve Plan Design

 
• By Derrick Gingery

Proposal would allow stakeholders to see data on REMS goals like provider training and the US FDA’s conclusions about their effectiveness.

Risk management concept hand drawn on chalkboard
Public REMS assessment summaries could help sponsors design better risk management plans going forward. • Source: Shutterstock

The US Food and Drug Administration is proposing to begin publicly releasing of assessment summaries for Risk Evaluation and Mitigation Strategies (REMS) as part of an effort to educate stakeholders and improve plan designs.

A REMS typically requires the sponsor to submit reports 18 months, three years and seven years after it is approved that look at various metrics. FDA uses the reports to...

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