FDA to Hold Public Meeting on Adverse Event eSubmissions Protocol Using ICH

FDA Headquarters

The U.S. Food and Drug Administration (FDA) will hold its third and final public meeting February 19 at its White Oak Campus in Maryland designed to help illuminate industry on how to handle the electronic submission of adverse events using the International Council for Harmonization (ICH) E2B(R3) standards.

Previous meetings were held last March and July. The purpose of the series is to provide the pharmaceutical industry and other interested parties with information on the plans, progress, and technical specifications to upgrade eSubmission standards for the premarket and postmarket safety surveillance programs managed by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

The all-day meetings focus on enhancements to eSubmission of Individual Case Safety Reports (ICSRs) in the FDA’s Adverse Event Reporting System (FAERS) using ICH E2B(R3).

Registration information for next month’s meeting, transcripts and webinars of prior meetings, and other background material can be found online.

Author: Michael Causey