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Review
. 2016 Mar;23(2):428-34.
doi: 10.1093/jamia/ocv063. Epub 2015 Jul 23.

Use of data mining at the Food and Drug Administration

Hesha J Duggirala  1 , Joseph M Tonning  2 , Ella Smith  3 , Roselie A Bright  4 , John D Baker  5 , Robert Ball  6 , Carlos Bell  2 , Susan J Bright-Ponte  5 , Taxiarchis Botsis  6 , Khaled Bouri  4 , Marc Boyer  3 , Keith Burkhart  2 , G Steven Condrey  7 , James J Chen  8 , Stuart Chirtel  3 , Ross W Filice  4 , Henry Francis  2 , Hongying Jiang  9 , Jonathan Levine  4 , David Martin  6 , Taiye Oladipo  3 , Rene O'Neill  9 , Lee Anne M Palmer  5 , Antonio Paredes  10 , George Rochester  10 , Deborah Sholtes  10 , Ana Szarfman  2 , Hui-Lee Wong  9 , Zhiheng Xu  9 , Taha Kass-Hout  4
Affiliations
Review

Use of data mining at the Food and Drug Administration

Hesha J Duggirala et al. J Am Med Inform Assoc. 2016 Mar.

Abstract

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.

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Conflict of interest statement

None.

References

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