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

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...