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.
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Complete Metadata
| @type | dcat:Dataset |
|---|---|
| accessLevel | public |
| bureauCode |
[
"009:10"
]
|
| contactPoint |
{
"fn": "openFDA",
"@type": "vcard:Contact",
"hasEmail": "mailto:open@fda.hhs.gov"
}
|
| description | 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. |
| distribution |
[
{
"@type": "dcat:Distribution",
"mediaType": "application/pdf",
"downloadURL": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm"
}
]
|
| identifier | 6c697267-fe17-4c66-8c6d-da38ab9b723b |
| issued | 2021-02-25 |
| keyword |
[
"cder",
"rems"
]
|
| landingPage | http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm |
| license | http://opendefinition.org/licenses/odc-odbl/ |
| modified | 2013-11-12 |
| programCode |
[
"009:002"
]
|
| publisher |
{
"name": "U.S. Food and Drug Administration",
"@type": "org:Organization"
}
|
| theme |
[
"FDA"
]
|
| title | Approved Risk Evaluation and Mitigation Strategies |
