Risk Evaluation and Mitigation Strategies:

Modifications and Revisions Guidance for Industry

The availability of a final guidance updated from the guidance of the same name, issued April 7, 2015

The Food and Drug Administration (FDA or Agency) announced the availability of a final guidance for industry entitled “Risk Evaluation and Mitigation Strategies: Modifications and Revisions” on July 10, 2019. This guidance 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 of the REMS. The guidance 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. The definitions of REMS modifications and revisions apply to all types of REMS. This guidance updates the guidance of the same name, issued April 7, 2015, including finalizing the portion that sets forth the submission procedures for REMS revisions.

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