FDA issues Risk Evaluation and Mitigation Strategies: Modifications and Revisions Final Guidance for Industry

Today, the U.S. Food and Drug Administration (FDA) issued a final guidance for industry entitled Risk Evaluation and Mitigation Strategies: Modifications and Revisions.  This guidance provides information on what types of changes to approved Risk Evaluation and Mitigation Strategies (REMS) will be considered modifications of the REMS and what types of changes will be considered revisions. This guidance also provides information on how REMS modifications and revisions should be submitted to FDA and how FDA intends to review and act on these submissions.

This guidance updates the guidance of the same name, issued on April 7, 2015, and finalizes the portion that sets forth the submission procedures for REMS revisions. The FDA thanks those who took the time to comment on the draft guidance. The agency carefully considered all of the comments received, including comments on the submission procedures portion, and revised the guidance as appropriate.