E2B(M) Questions and Answers

Issue Date: March 9, 2005
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Efficacy
Status: Final

E2B(M) Questions and Answers

This question and answer (Q&A) guidance is intended to assist applicants who plan the electronic transmission of individual case safety reports (ICSRs) to the Food and Drug Administration (FDA). The guidance is a revision of the E2B(M) Q&A guidance that was published in May 2004.

Download the Guidance Document

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