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 Duggirala¹, Joseph M Tonning², Ella Smith³, Roselie A Bright⁴, John D Baker⁵, Robert Ball⁶, Carlos Bell², Susan J Bright-Ponte⁵, Taxiarchis Botsis⁶, Khaled Bouri⁴, Marc Boyer³, Keith Burkhart², G Steven Condrey⁷, James J Chen⁸, Stuart Chirtel³, Ross W Filice⁴, Henry Francis², Hongying Jiang⁹, Jonathan Levine⁴, David Martin⁶, Taiye Oladipo³, Rene O'Neill⁹, Lee Anne M Palmer⁵, Antonio Paredes¹⁰, George Rochester¹⁰, Deborah Sholtes¹⁰, Ana Szarfman², Hui-Lee Wong⁹, Zhiheng Xu⁹, Taha Kass-Hout⁴

Affiliations

¹ Center for Veterinary Medicine, FDA Hesha.Duggirala@fda.hhs.gov.
² Center for Drug Evaluation and Research, FDA.
³ Center for Food Safety and Applied Nutrition, FDA.
⁴ Office of the Commissioner, FDA.
⁵ Center for Veterinary Medicine, FDA.
⁶ Center for Biologics Evaluation and Research, FDA.
⁷ Office of Regulatory Affairs, FDA.
⁸ National Center for Toxicological Research, FDA.
⁹ Center for Devices and Radiological Health, FDA.
¹⁰ Center for Tobacco Products, FDA.

PMID: 26209436
PMCID: PMC11740535
DOI: 10.1093/jamia/ocv063

Review

Use of data mining at the Food and Drug Administration

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

. 2016 Mar;23(2):428-34.

doi: 10.1093/jamia/ocv063. Epub 2015 Jul 23.

Authors

Affiliations

¹ Center for Veterinary Medicine, FDA Hesha.Duggirala@fda.hhs.gov.
² Center for Drug Evaluation and Research, FDA.
³ Center for Food Safety and Applied Nutrition, FDA.
⁴ Office of the Commissioner, FDA.
⁵ Center for Veterinary Medicine, FDA.
⁶ Center for Biologics Evaluation and Research, FDA.
⁷ Office of Regulatory Affairs, FDA.
⁸ National Center for Toxicological Research, FDA.
⁹ Center for Devices and Radiological Health, FDA.
¹⁰ Center for Tobacco Products, FDA.

PMID: 26209436
PMCID: PMC11740535
DOI: 10.1093/jamia/ocv063

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.

Published by Oxford University Press on behalf of the American Medical Informatics Association 2015. This work is written by US Government employees and is in the public domain in the US.

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Conflict of interest statement

None.

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References

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Use of data mining at the Food and Drug Administration

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Use of data mining at the Food and Drug Administration

Authors

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Abstract

Conflict of interest statement

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