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Risk evaluation and mitigation strategy (REMS)

Risk evaluation and mitigation strategy (REMS)

 

Risk Evaluation and Mitigation Strategies (REMS) are drug safety programs required by the U.S. Food and Drug Administration (FDA) for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. This page provides links to the REMS Programs for certain Janssen Pharmaceutical, Inc., and Janssen Biotech, Inc., products.

 

Updated: 11/3/2023

Updated: 6/12/2024

Updated: 2/13/2024

Updated: 11/18/2022