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GUIDANCE DOCUMENT

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

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2013-D-0755
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 Online

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-2013-D-0755.

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