FDA: Risk Evaluation and Mitigation Strategies: Modifications and Revisions

This guidance provides information on how the FDA will define and process submissions from application holders for modifications and revisions to approved risk evaluation and mitigation strategies (REMS). Specifically, this guidance provides information on what types of changes to REMS will be considered modifications of the REMS, as described in section 505-1(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and what types of changes will be considered revisions of the REMS.