This paper describes how signals are generated from postmarketing adverse drug experience reports at FDA. This is a companion paper to “The Evaluation of Postmarketing Adverse Drug Experience Reports at FDA: Part I,” which described the development of the computerized database and processing of reports, and the clinical review of individual reports. This paper follows with a description of the way signals are generated from various sources, including individual adverse drug experience (ADE) reports in the Food and Drug Administration's (FDA) spontaneous reporting system (SRS).
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