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Limitations and strengths of spontaneous reports data
1Office of the Commissioner, US Food and Drug Administration, Rockville, Maryland 20857, USA.
Clinical Therapeutics
|January 23, 1999
Abstract:
US Food and Drug Administration (FDA) monitoring of the continued safety of marketed medical products depends greatly on spontaneous reporting of serious adverse events by health professionals. Despite its inherent limitations, the national postmarketing surveillance system provides vital information of clinical importance.