← FDA GUIDANCE
FDA GUIDANCE · FINALOctober 1, 2026

E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status
Final
Topic
ICH-Efficacy
Issue date
October 1, 2026
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