Electronic Submission of Adverse Event Reports to the Food and Drug Administration Adverse Event Reporting System Using International Council for Harmonisation E2B(R3) Standards; Public Meetings; Request for Comments

Resumo

The Food and Drug Administration (FDA, the Agency, or we) is re-announcing three public meetings entitled "Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) Using International Council for Harmonisation (ICH) E2B(R3) Standards." The purpose of these public meetings is to provide the pharmaceutical industry and other interested parties with information on the plans, progress, and technical specifications to upgrade electronic submission standards for drug, biological, and drug/ biologic-led combination products 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). These meetings will focus on enhancements to electronic submission of Individual Case Safety Reports (ICSRs) in FAERS using ICH E2B(R3) standards. FDA is seeking input from stakeholders as it fulfills its commitment to implement ICH E2B(R3) standards by holding three public meetings. FDA will use the information provided by the public to inform the enhancements to FAERS required for the implementation of ICH E2B(R3) standards and relevant regional vari