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. There are different procedures for submission of REMS modifications and revisions to the FDA, as well as different time frames for FDA review and action on such changes. This guidance provides information on how REMS modifications and revisions should be submitted to the FDA, and the FDA’s process for reviewing and acting on these submissions. The definitions of REMS modifications and revisions set forth in this guidance apply to all types of REMS. This guidance is issued pursuant to sections 505­-1(h)(2)(A)(ii), (iii), and (iv) of the FD&C Act.


This guidance does not address additional procedures that may apply to application holders proposing changes to REMS that are part of a single shared system. The FDA intends to address these procedures in future guidance.


The information contained in this guidance pertaining to REMS modification and revision submission procedures for application holders and the time frames for the FDA review and action supersedes the information on the same topic contained in the draft guidance for industry Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications.


This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on major and minor modifications of REMS. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. Insofar as this guidance establishes the modifications to an approved REMS that may be implemented following notification to the Secretary under section 505-1(h)(2)(A)(iv) — here referred to as REMS revisions — it has binding effect, except for the portions of the guidance setting forth the submission procedures for REMS revisions, which will, when final, have binding effect.



Posted on the FDA website on 2 April 2015