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U.S. Department of Health and Human Services

For Industry

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REMS Integration Initiative

In 2011, FDA created the REMS Integration Initiative, designed to evaluate and improve our implementation of Risk Evaluation and Mitigation Strategies (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

    • improved integration of REMS into the existing and evolving healthcare system 

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

To support the REMS Integration Initiative, the FDA Center for Drug Evaluation and Research REMS Integration Steering Committee (RISC) oversees the activities of three subordinate work groups whose deliverables will fulfill commitments FDA has made under the reauthorized Prescription Drug User Fee Act (PDUFA V).

  • The Policy Work Group is currently developing a draft guidance to provide more information about how FDA applies the statutory criteria to determine whether a REMS is necessary.

  • The Design and Standardization Work Group is leading FDA’s efforts to identify best practices to incorporate into REMS design, as well as appropriate ways to standardize REMS tools and integrate REMS into the healthcare delivery system. This group will solicit stakeholder input within the next year and expects to develop a report of its findings.

  • The Evaluation Work Group is leading FDA’s efforts to develop an evidence-based approach to assessing the effectiveness and burden of REMS. In addition to a June 2012 public workshop on survey methodologies, the Evaluation Work Group will obtain additional stakeholder input and expects to publish a draft guidance on evaluation methodologies.

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Meeting Information

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