# 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 – FDA Guidance

Source: https://www.keypedia.com/guidances/guidance-document/e2br3-electronic-transmission-of-individual-case-safety-reports-implementation-guide-data-elements-and-message-specification-and-appendix-to-the-implementation-guide-backwards-and-forwards-compatibility/94a3168c-91a2-43a4-93f5-072183492a1f

> FDA guidance document: 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. Issue date: October 01, 2026. Get complete insights and analysis.

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## Details

- Title: 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
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2026-10-01
- Last Changed: 2026-10-01
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2011-D-0720">FDA-2011-D-0720</a>

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