USA – Risk Evaluation and Mitigation Strategies: Modifications and Revisions

I. INTRODUCTION

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

This guidance is issued pursuant to section 505-1(h)(2)(A)(ii), (iii), and (iv) of the
FD&C Act and section 1132(c) of Public Law 112-144.  This guidance applies to all types of REMS, including REMS that are part of a shared system (SS REMS).

This guidance does not address additional submission procedures that may apply to application holders proposing changes to REMS that are part of a shared system and that use a drug master file (DMF) for their REMS submissions.

This guidance is being issued consistent with the FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on changes to REMS. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public…