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GUIDANCE DOCUMENT

E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards and Forwards Compatibility April 2022

Download the Final Guidance Document
Final
Docket Number:
FDA-2011-D-0720
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This document is an appendix to the Implementation Guide (IG) for the ‘International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Electronic Transmission of Individual Case Safety Reports (ICSRs)’.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-D-0720.

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