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.
 

Submit Comments

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.