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GUIDANCE DOCUMENT

E2B International Conference on Harmonisation; Guidance on Data Elements for Transmission of Individual Case Safety Reports January 1998

Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

FDA is publishing a guidance entitled ‘‘E2B Data Elements for Transmission of Individual Case Safety Reports.’’ The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.