FDA DRAFT Guidance for REMS Format and Content

Published: January 22, 2010
FDA DRAFT Guidance for REMS Format and Content

This document provides guidance to industry on:

  • The format and content of a proposed risk evaluation and mitigation strategy (REMS), including REMS supporting documentation
  • The content of assessments and proposed modifications of approved REMS
  • What identifiers to use on REMS documents
  • How to communicate with FDA about a REMS

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