title: The FDA's sentinel initiative--A comprehensive approach to medical product surveillance.
abstract: In May 2008, the Department of Health and Human Services announced the launch of the Sentinel Initiative by the US Food and Drug Administration (FDA) to create the Sentinel System, a national electronic system for medical product safety surveillance. This system complements existing FDA surveillance capabilities that track adverse events reported after the use of FDA regulated products by allowing the FDA to proactively assess the safety of these products.
authors.affiliation: Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: R
authors.initials: R
authors.lastname: Ball
authors.affiliation: Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: M
authors.initials: M
authors.lastname: Robb
authors.affiliation: Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: S A
authors.initials: SA
authors.lastname: Anderson
authors.affiliation: Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: G
authors.initials: G
authors.lastname: Dal Pan
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D004864:Equipment and Supplies / Q000009:adverse effects / Q000592:standards; D006801:Humans; D060735:Pharmacovigilance; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*