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

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 was required to open a public docket and seek comments under a provision in the 2022 Food and Drug Omnibus Reform Act (FDORA)