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

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

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