Approved Risk Evaluation and Mitigation Strategies (REMS)

Approved Risk Evaluation and Mitigation Strategies (REMS)
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. The table below provides a list of REMS that have been approved by FDA.
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http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm