A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports

Conclusions By concentrating on AE types with already demonstrated interest to FDA, we constructed a signaling system that provided focus regarding drug–AE pairs and suitable accuracy with regard to the issuance of FDA labeling changes. We suggest that focus on historical regulatory actions may increase the utility of pharmacovigilance signaling systems.
Source: Drug Safety - Category: Drugs & Pharmacology Source Type: research