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.
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.
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