Business · 06/04/2026Updated: 10/16/2026 · 1 min read
FDA Updates Data Standard for Postmarketing ICSRs
Summary
The FDA is requiring postmarketing individual case safety report submissions to use the International Council of Harmonisation E2B(R3) data standards starting October 1, 2026, via the Electronic Submissions Gateway Next Generation.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →