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# REMS Modifications and Revisions Guidance
- URL: https://www.fdaweb.com/rems-modifications-and-revisions-guidance/
- Published: 2019-07-09T12:00:00.000Z
- Updated: 2026-09-15T01:36:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144484

FDA has issued a guidance, *Risk Evaluation and Mitigation Strategies: Modifications and Revisions*, with information on how the agency defines the types of changes to approved risk evaluation and mitigation strategies (REMS), and how it will process submissions from application holders for changes to REMS. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/risk-evaluation-and-mitigation-strategies-modifications-and-revisions-guidance-industry-0?ref=fdaweb.com) specifically provides information on what types of changes to REMS will be considered modifications of the REMS and what type of changes will be considered revisions of the REMS (changes that may be implemented following notification to FDA).

The guidance applies to all types of REMS, including those that are part of a shared system. It 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 for their REMS submissions.

Contents of the guidance are Introduction, Background, Policy, Submission Procedures, FDA Time Frames for REM Changes, and Contact Information, with an Appendix on submission procedures for changes to approved REMS.