safety signal
- Guideline or reference source
- EMA Glossary of terms
- Definition
- Information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature.
- Broader Term
- signal
- Narrower Term
- newly identified signal
- Related Term
- drug recall
- pharmacovigilance
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