Identifying and Quantifying the Accuracy of Product Name Attribution of US-Sourced Adverse Event Reports in MedWatch of Somatropins and Insulins

Conclusions:
The completion and accuracy rates of FAERS data on biologics observed in this study are consistent with those observed in earlier studies and suggest that traceability in adverse event reports can be improved through more consistent use of brand names or other product specific identifiers and through more frequent inclusion of lot numbers.

Source: Therapeutic Innovation and Regulatory Science - August 25, 2015 Category: Drugs & Pharmacology Authors: Stergiopoulos, S., Brown, C. A., Grampp, G., Felix, T., Getz, K. A. Tags: Product Safety Source Type: research