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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

Overview of Risk Evaluation and Mitigation Strategies (REMS) for Health Care Providers

Step Status
Educational Content ✘
Posttest ✘
Evaluation ✘
Starts On: Fri, 6/10/22: 12:00 AM EDT
Ends On: Sun, 12/31/23: 12:00 AM EST
Type: Enduring Material
Credits: 1
Description: This webinar will provide an overview of REMS and discuss how the REMS safety requirements impact prescribers, dispensers and patients. Participants should gain an understanding of the REMS authorities, how REMS are implemented, and the entities that provide oversite and support. REMS is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that
medication. While all medications have labeling that informs health care stakeholders about medication risks, only a few medications require a REMS.
Objectives:
  • Describe when the FDA can require a REMS.
  • List the different elements of Risk Evaluation Mitigation Strategies.
  • Identify REMS resources available to healthcare professionals.
  • Discuss the possible enforcement actions by the FDA.
Additional Information: Review the Activity Announcement for additional details: Announcement Form

Additional Resources: REMSSlides