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 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.