Exploring the FDA adverse event reporting system to generate hypotheses for monitoring of disease characteristics.
The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) is a database for postmarketing drug safety monitoring and influences changes in FDA safety guidance documents such as drug labels. The number of cases in the FAERS has rapidly increased with the improvement of submission methods and data standards and thus has become an important resource for regulatory science. Although the FAERS has been predominantly used for safety signal detection, this study explored its utility for disease characteristics.
Office of Scientific Coordination, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas, USA.
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H
Fang
Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas, USA.
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Z
Su
Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas, USA.
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Y
Wang
Biomedical Informatics Research Center, Marshfield Clinic Research Foundation, Marshfield, Wisconsin, USA.
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A
Miller
Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas, USA.
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Z
Liu
Office of Scientific Coordination, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas, USA.
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PC
Howard
Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas, USA.
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Tong
Biomedical Informatics Research Center, Marshfield Clinic Research Foundation, Marshfield, Wisconsin, USA.
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Lin
D016907:Adverse Drug Reaction Reporting Systems; D057225:Data Mining; D016208:Databases, Factual; D004348:Drug Labeling; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration