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GUIDANCE DOCUMENT

E2B(M) Questions and Answers March 2005

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-1996-D-0168
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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.
 

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

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1996-D-0168.

 
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