title: Informatic tools and approaches in postmarketing pharmacovigilance used by FDA.
abstract: The safety profile of newly approved drugs and therapeutic biologics is less well developed by pre-marketing clinical testing than is the efficacy profile. The full safety profile of an approved product is established during years of clinical use. For nearly 40 years, the FDA has relied on the voluntary reporting of adverse events by healthcare practitioners and patients to help establish the safety of marketed products. Epidemiologic studies, including case series, secular trends, case-control and cohort studies, are used to supplement the investigation of a safety signal. Ideally, active surveillance systems would supplement the identification and exploration of safety signals. The FDA has implemented a number of initiatives to help identify safety problems with drugs and continues to evaluate their efforts.
authors.affiliation: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903-0002, USA. joyce.weaver@fda.hhs.gov
authors.forename: Joyce
authors.initials: J
authors.lastname: Weaver
authors.forename: Mary
authors.initials: M
authors.lastname: Willy
authors.forename: Mark
authors.initials: M
authors.lastname: Avigan
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards / Q000639:trends; D000818:Animals; D015507:Drugs, Investigational / Q000009:adverse effects / Q000494:pharmacology; D006801:Humans; D008490:Medical Informatics / Q000592:standards* / Q000639:trends; D011358:Product Surveillance, Postmarketing / Q000592:standards* / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards* / Q000639:trends
chemical_list: D015507:Drugs, Investigational