Use of data mining at the Food and Drug Administration

J Am Med Inform Assoc. 2016 Mar;23(2):428-34. doi: 10.1093/jamia/ocv063. Epub 2015 Jul 23.


Objectives: This article summarizes past and current data mining activities at the United States Food and Drug Administration (FDA).

Target audience: 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.

Scope: 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.

Keywords: data mining; disproportionality analysis; pharmacovigilance.

Publication types

  • Review

MeSH terms

  • Data Mining* / statistics & numerical data
  • Pharmacovigilance
  • Product Surveillance, Postmarketing*
  • United States
  • United States Food and Drug Administration*