Limitations and strengths of spontaneous reports data

Clin Ther. 1998:20 Suppl C:C40-4. doi: 10.1016/s0149-2918(98)80007-6.


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.

Publication types

  • Review

MeSH terms

  • Adverse Drug Reaction Reporting Systems / organization & administration*
  • Adverse Drug Reaction Reporting Systems / standards
  • Cost-Benefit Analysis
  • Drug-Related Side Effects and Adverse Reactions
  • Humans
  • Population