- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter 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.
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:
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.