FDA to Hold Public Meetings on Electronic Submission of Adverse Event Reports Using ICH E2B(R3) Standards

Summary

The Food and Drug Administration (FDA) is re-announcing three public meetings to gather input from the pharmaceutical industry and other stakeholders on the upgrade of electronic submission standards for drug and biological products, with a focus on enhancing Individual Case Safety Reports (ICSRs) in the FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) standards.