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  1. Risk Evaluation and Mitigation Strategies | REMS

REMS News, Education, Meetings and Improvement Efforts

The REMS Integration Initiative

FDA established the Risk Evaluation and Mitigation Strategies (REMS) Integration Initiative to evaluate and improve the implementation of its REMS authorities. The goals of the REMS Integration Initiative include:

  • Developing guidance on how to apply the statutory criteria to determine when a REMS is required,
  • Improved standardization and assessment of REMS, and
  • Improved integration of REMS into the existing and evolving healthcare system. 

This initiative incorporated input from stakeholders on issues and challenges associated with the development, implementation and assessment of REMS.

The following is information related to the work of the REMS Integration Initiative:

REMS Education

Public and Expert Meetings on REMS

Other REMS News and Reports

 Archived information

Current REMS

FDA maintains a website listing medications with approved REMS that are currently active and their associated materials, at (REMS@FDA).

 

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