The FAERS database, which follows FDA Adverse event reporting regulations, is designed specifically to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products.
The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse events and medication error reports submitted to FDA. Compliant with the reporting guidance ICH E2B2 issued by the International Conference on Harmonisation, FDA uses FAERS data to monitor, identify and analyze adverse events and medication errors.
