title: Use of data mining at the Food and Drug Administration.
abstract: OBJECTIVE
  This article summarizes past and current data mining activities at the United States Food and Drug Administration (FDA).
  
  
  BACKGROUND
  We address data miners in all sectors, anyone interested in the safety of products regulated by the FDA (predominantly medical products, food, veterinary products and nutrition, and tobacco products), and those interested in FDA activities.
  
  
  METHODS
  Topics include routine and developmental data mining activities, short descriptions of mined FDA data, advantages and challenges of data mining at the FDA, and future directions of data mining at the FDA.
authors.affiliation: Center for Veterinary Medicine, FDA Hesha.Duggirala@fda.hhs.gov.
authors.forename: Hesha J
authors.initials: HJ
authors.lastname: Duggirala
authors.affiliation: Center for Drug Evaluation and Research, FDA.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Tonning
authors.affiliation: Center for Food Safety and Applied Nutrition, FDA.
authors.forename: Ella
authors.initials: E
authors.lastname: Smith
authors.affiliation: Office of the Commissioner, FDA.
authors.forename: Roselie A
authors.initials: RA
authors.lastname: Bright
authors.affiliation: Center for Veterinary Medicine, FDA.
authors.forename: John D
authors.initials: JD
authors.lastname: Baker
authors.affiliation: Center for Biologics Evaluation and Research, FDA.
authors.forename: Robert
authors.initials: R
authors.lastname: Ball
authors.affiliation: Center for Drug Evaluation and Research, FDA.
authors.forename: Carlos
authors.initials: C
authors.lastname: Bell
authors.affiliation: Center for Veterinary Medicine, FDA.
authors.forename: Susan J
authors.initials: SJ
authors.lastname: Bright-Ponte
authors.affiliation: Center for Biologics Evaluation and Research, FDA.
authors.forename: Taxiarchis
authors.initials: T
authors.lastname: Botsis
authors.affiliation: Office of the Commissioner, FDA.
authors.forename: Khaled
authors.initials: K
authors.lastname: Bouri
authors.affiliation: Center for Food Safety and Applied Nutrition, FDA.
authors.forename: Marc
authors.initials: M
authors.lastname: Boyer
authors.affiliation: Center for Drug Evaluation and Research, FDA.
authors.forename: Keith
authors.initials: K
authors.lastname: Burkhart
authors.affiliation: Office of Regulatory Affairs, FDA.
authors.forename: G Steven
authors.initials: GS
authors.lastname: Condrey
authors.affiliation: National Center for Toxicological Research, FDA.
authors.forename: James J
authors.initials: JJ
authors.lastname: Chen
authors.affiliation: Center for Food Safety and Applied Nutrition, FDA.
authors.forename: Stuart
authors.initials: S
authors.lastname: Chirtel
authors.affiliation: Office of the Commissioner, FDA.
authors.forename: Ross W
authors.initials: RW
authors.lastname: Filice
authors.affiliation: Center for Drug Evaluation and Research, FDA.
authors.forename: Henry
authors.initials: H
authors.lastname: Francis
authors.affiliation: Center for Devices and Radiological Health, FDA.
authors.forename: Hongying
authors.initials: H
authors.lastname: Jiang
authors.affiliation: Office of the Commissioner, FDA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Levine
authors.affiliation: Center for Biologics Evaluation and Research, FDA.
authors.forename: David
authors.initials: D
authors.lastname: Martin
authors.affiliation: Center for Food Safety and Applied Nutrition, FDA.
authors.forename: Taiye
authors.initials: T
authors.lastname: Oladipo
authors.affiliation: Center for Devices and Radiological Health, FDA.
authors.forename: Rene
authors.initials: R
authors.lastname: O'Neill
authors.affiliation: Center for Veterinary Medicine, FDA.
authors.forename: Lee Anne M
authors.initials: LA
authors.lastname: Palmer
authors.affiliation: Center for Tobacco Products, FDA.
authors.forename: Antonio
authors.initials: A
authors.lastname: Paredes
authors.affiliation: Center for Tobacco Products, FDA.
authors.forename: George
authors.initials: G
authors.lastname: Rochester
authors.affiliation: Center for Tobacco Products, FDA.
authors.forename: Deborah
authors.initials: D
authors.lastname: Sholtes
authors.affiliation: Center for Drug Evaluation and Research, FDA.
authors.forename: Ana
authors.initials: A
authors.lastname: Szarfman
authors.affiliation: Center for Devices and Radiological Health, FDA.
authors.forename: Hui-Lee
authors.initials: HL
authors.lastname: Wong
authors.affiliation: Center for Devices and Radiological Health, FDA.
authors.forename: Zhiheng
authors.initials: Z
authors.lastname: Xu
authors.affiliation: Office of the Commissioner, FDA.
authors.forename: Taha
authors.initials: T
authors.lastname: Kass-Hout
mesh_terms: D057225:Data Mining / Q000706:statistics & numerical data; D060735:Pharmacovigilance; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration
keywords: data mining; disproportionality analysis; pharmacovigilance