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Switching REMS Vendors: AAM Calls For FDA Guidance On Performance Standards

 
• By Brenda Sandburg

The trade association says it is impractical for a sponsor or REMS administrator to conduct a ‘failure modes and effects analysis’ to plan for system failures while United BioSource and the National Council for Prescription Drug Programs supports the testing.

Risk mitigation
The FDA gets advice on dealing with changes in vendors administering Risk Evaluation and Mitigation Strategies • Source: Shutterstock

The Association for Accessible Medicines recommends that the US Food and Drug Administration provide guidance on operational performance standards for Risk Evaluation and Mitigation Strategies (REMS) administration and hold a public meeting on obtaining stakeholder input and testing new REMS components.

AAM, a generic industry trade association, submitted comments to the agency on factors that should be considered when reviewing requests from sponsors to change third-party REMS vendors. The FDA...

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