This guidance provides firms with information on the appropriate electronic file format to use when electronically submitting to FDA postmarket, non-expedited individual case safety reports (ICSRs) on adverse drug experiences. Non-expedited ICSRs are the case reports required to be submitted at the time firms submit their periodic adverse (drug) experience reports (21 CFR 314.80(c)(2)(ii)(b) and 600.80(c)(2)(ii)(B)). This guidance explains that firms that previously submitted non-expedited ICSRs in an electronic format that is not supported by FDA should contact the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) and resubmit their non-expedited ICSRs in a compatible electronic format.


This guidance does not apply to reports of adverse experiences associated with use of prophylactic vaccines, human cells, tissues, cellular and tissue-based products, whole blood, or components of whole blood.


Posted on the FDA website on 24 July 2013