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Clin Ther. 1998;20 Suppl C:C40-4.

Limitations and strengths of spontaneous reports data.

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1
Office of the Commissioner, US Food and Drug Administration, Rockville, Maryland 20857, USA.

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.

PMID:
9915089
[Indexed for MEDLINE]
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