Approved Risk Evaluation and Mitigation Strategies

Published by U.S. Food and Drug Administration | U.S. Department of Health & Human Services | Metadata Last Checked: August 09, 2025 | Last Modified: 2013-11-12

The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.

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cder rems

Complete Metadata

bureauCode	[ "009:10" ]
identifier	6c697267-fe17-4c66-8c6d-da38ab9b723b
issued	2021-02-25
landingPage	http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm
programCode	[ "009:002" ]
theme	[ "FDA" ]

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