Use of data mining at the Food and Drug Administration

Author:

Duggirala Hesha J1,Tonning Joseph M2,Smith Ella3,Bright Roselie A4,Baker John D1,Ball Robert5,Bell Carlos2,Bright-Ponte Susan J1,Botsis Taxiarchis5,Bouri Khaled4,Boyer Marc3,Burkhart Keith2,Steven Condrey G6,Chen James J7,Chirtel Stuart3,Filice Ross W4,Francis Henry2,Jiang Hongying8,Levine Jonathan4,Martin David5,Oladipo Taiye3,O’Neill Rene8,Palmer Lee Anne M.1,Paredes Antonio9,Rochester George9,Sholtes Deborah9,Szarfman Ana2,Wong Hui-Lee8,Xu Zhiheng8,Kass-Hout Taha4

Affiliation:

1. Center for Veterinary Medicine, FDA

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 Biologics Evaluation and Research, FDA

6. Office of Regulatory Affairs, FDA

7. National Center for Toxicological Research, FDA

8. Center for Devices and Radiological Health, FDA

9. Center for Tobacco Products, FDA

Abstract

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.

Publisher

Oxford University Press (OUP)

Subject

Health Informatics

Reference61 articles.

1. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment;Guidance for Industry,, 2005

2. A model for the future conduct of pharmacovigilance;Waller;Pharnaccoepidemiol Drug Saf.,2003

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