Review
doi: 10.1016/s0149-2918(98)80007-6.
Limitations and strengths of spontaneous reports data
Affiliations
- PMID: 9915089
- DOI: 10.1016/s0149-2918(98)80007-6
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Review
Limitations and strengths of spontaneous reports data
Clin Ther.
1998.
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.
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