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GUIDANCE DOCUMENT

E2BM Data Elements for Transmission Of Individual Case Safety Reports April 2002

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 guidance is intended to assist applicants who plan to submit individual case safety reports (ICSRs) to FDA. This guidance revises E2B step 4 document signed off by the International Conference on Harmonisation (ICH) in July 1997 and issued by the FDA in January 1998. 
 


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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-1996-D-0168.

 
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