title: The Food and Drug Administration risk evaluation and mitigation strategy.
abstract: The Food and Drug Administration Amendments Act of 2007 extended the agency's regulatory authority over drug products that have been shown to place patients at risk. This Act authorizes the FDA to require pharmaceutical manufacturers and distributors to ensure that the safety of their products continue to outweigh the risks. This article discusses in more detail the proposed elements of an acceptable Risk Evaluation and Mitigation Strategy (REMS) for any drug product, including extended-release opioid analgesics.
authors.affiliation: Care Service, H Lee Moffitt Cancer Center and Research Institute in Tampa, Florida 33612-9412, USA. david.craig@moffitt.org
authors.forename: David S
authors.initials: DS
authors.lastname: Craig
mesh_terms: D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D018570:Risk Assessment / Q000331:legislation & jurisprudence / Q000379:methods; D012308:Risk Management / Q000331:legislation & jurisprudence / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D004364:Pharmaceutical Preparations