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Approved Risk Evaluation and Mitigation Strategies
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.
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" ] |
