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GUIDANCE DOCUMENT

Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers July 2013

Final

Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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)3 or the Center for Biologics Evaluation and Research (CBER) and resubmit their non-expedited ICSRs in a compatible electronic format.


Submit Comments

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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.