FDA Issues Draft REMS Guidance


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-11-2015 15:31

  

The US Food and Drug Administration (FDA) has issued draft guidance, Risk Evaluation and Mitigation Strategies: Modifications and Revisions--Guidance for Industry, to provide information on how the FDA will define and process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Specifically, this draft guidance provides information on what types of changes to REMS will be considered modifications of the REMS and what types of changes will be considered revisions of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 the FDA, as well as different time frames for FDA review and action on such changes. This draft guidance provides information on how REMS modifications and revisions should be submitted to the FDA, and the FDA’s process for reviewing and acting on these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 the guidance apply to all types of REMS. The draft guidance does not address additional procedures that may apply to application holders proposing changes to REMS that are part of a single shared system.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.

Source: FDA

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