Adverse drug experience (ADE) information processing is a surveillance activity at the Food and Drug Administration (FDA) that monitors the safety of drugs after marketing. This paper is an overview of the spontaneous Adverse Drug Reaction Information System, postmarketing surveillance activities, and samples of summary reports used to identify safety issues.
Coding Symbols for Thesaurus of Adverse Drug Reaction Terms (COSTART). 4th ed.Rockville, MD: Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Division of Epidemiology and Surveillance; 1994.
