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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research

Advancing Transparency and Regulatory Science Activities on the Risk Evaluation and Mitigation Strategy (REMS)

Step Status
Educational Content
Starts On: Mon, 2/12/24: 12:00 AM EST
Ends On: Thu, 2/11/27: 12:00 AM EST
Type: Enduring Material
Credits: 1
Description: This enduring material will describe the Risk Evaluation and Mitigation Strategy (REMS) Integration Project, REMS structured product labeling (SPL), and the REMS Public Dashboard. The REMS integration project entails development of an open source, innovative, stakeholder-driven approach to use contemporary data standards and technologies for integration of REMS. The REMS SPL can be used to capture and present REMS information in a format that is easily shared with stakeholders and readily incorporated into health information technology. The REMS Public Dashboard, launched in December 2021, was developed to improve access and transparency of REMS information. The FDA REMS Public Dashboard can be accessed through the REMS@FDA website. These innovative tools and initiatives are intended to support target users such as healthcare providers, patients, researchers, pharmaceutical companies, or regulators.
  • Describe the approach for the REMS Integration Prototype and Use Case and how it can reduce REMS implementation burden
  • Explain the REMS integration pilots and opportunities to contribute to the REMS Integration Use Case
  • Review how the REMS SPL files can assist health care professionals in identifying REMS drugs and their corresponding requirements
  • Discuss how to use the REMS Public Dashboard
Additional Information: Review the Activity Announcement for additional details: Announcement Form

Additional Resources: SLIDES