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

Summary

The Food and Drug Administration (FDA) is hosting three public meetings to gather input from stakeholders on the implementation of International Council for Harmonisation (ICH) E2B(R3) standards for electronic submission of adverse event reports to the FDA Adverse Event Reporting System (FAERS). The meetings aim to enhance the electronic submission of Individual Case Safety Reports (ICSRs) in FAERS using ICH E2B(R3) standards, in support of the FDA's commitment to implement these standards.