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# Guide on REMS Modifications and Revisions
- URL: https://www.fdaweb.com/guide-on-rems-modifications-and-revisions/
- Published: 2019-07-10T12:00:00.000Z
- Updated: 2026-09-15T01:37:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144494

*Federal Register* notice: FDA has made available a guidance entitled “Risk Evaluation and Mitigation Strategies: Modifications and Revisions.” The document provides information on how FDA will define and process submissions for modifications and revisions of risk evaluation and mitigation strategies (REMS), as well as information on what types of changes to approved REMS will be considered modifications or revisions. It also provides instructions to application holders related to procedures for submission of REMS modifications and revisions to FDA as well as different timeframes for FDA’s review of and action on such changes. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-07-10/pdf/2019-14663.pdf?ref=fdaweb.com).