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

Summary

The Food and Drug Administration (FDA) is hosting a series of public meetings to gather input on the electronic submission of adverse event reports to the FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) standards, with a focus on enhancements to Individual Case Safety Reports (ICSRs) in FAERS.