{
  "@type": "dcat:Dataset",
  "accessLevel": "public",
  "bureauCode": [
    "009:10"
  ],
  "contactPoint": {
    "@type": "vcard:Contact",
    "fn": "openFDA",
    "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",
      "downloadURL": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm",
      "mediaType": "application/pdf"
    }
  ],
  "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": {
    "@type": "org:Organization",
    "name": "U.S. Food and Drug Administration"
  },
  "theme": [
    "FDA"
  ],
  "title": "Approved Risk Evaluation and Mitigation Strategies"
}