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.
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.