FDA Issues Guidance on Risk Evaluation and Mitigation Strategies: Modifications and Revisions

FDA has announced the availability of a guidance for industry entitled “Risk Evaluation and Mitigation Strategies: Modifications and Revisions.” This guidance provides information on how FDA will define and process submissions for modifications and revisions to risk evaluation and mitigation strategies (REMS), as well as information on what types of changes to approved REMS will be considered modifications of the REMS and what types of changes will be considered revisions of the REMS.

There are different procedures for submission of REMS modifications and revisions to FDA, as well as different timeframes for FDA review and action of such changes. In addition, this guidance provides information on how REMS modifications and revisions should be submitted to FDA and how FDA intends to review and act on these submissions. The definitions of REMS modifications and revisions apply to all types of REMS.