FDA issues final guidance for Industry on Risk Evaluation and Mitigation Strategies
10th July 2019
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 The FDA thanks those who took the time to comment on the draft guidance.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.