Adverse-Drug-Reaction Monitoring

The U.S. Food and Drug Administration (FDA) has long been conducting a program to monitor reported adverse drug reactions to approved drugs. The purpose of this paper is to review the rationale for monitoring adverse drug reactions, to describe the current program, and to encourage physician partici...

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Bibliographic Details
Published inThe New England journal of medicine Vol. 314; no. 24; pp. 1589 - 1592
Main Author Faich, Gerald A
Format Journal Article
LanguageEnglish
Published United States Massachusetts Medical Society 12.06.1986
Subjects
Cervical cancer
Clinical trials
Drug and Narcotic Control
Drug Information Services
Drug Labeling
Drug-Related Side Effects and Adverse Reactions
Drugs
Epidemiology
Evaluation Studies as Topic
FDA approval
Food
Health surveillance
Marketing
Pharmaceutical industry
Physician's Role
Physicians
Product safety
Product Surveillance, Postmarketing
United States
United States Food and Drug Administration
United States
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Summary:The U.S. Food and Drug Administration (FDA) has long been conducting a program to monitor reported adverse drug reactions to approved drugs. The purpose of this paper is to review the rationale for monitoring adverse drug reactions, to describe the current program, and to encourage physician participation in the program. The program began in the late 1950s, after the registration by the American Medical Association of cases of aplastic anemia due to chloramphenicol. 1 It expanded greatly when the 1962 revision of the Food and Drug Act required the pharmaceutical industry to report adverse drug reactions to the FDA. Since 1969, . . .
ISSN:0028-4793
1533-4406
DOI:10.1056/NEJM198606123142427