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GUIDANCE DOCUMENT

Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) November 2016

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2013-D-0349
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance describes the conditions under which applicants can use an alternative reporting format, the International Council for Harmonisation (ICH)3 E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER), in place of the U.S. periodic adverse drug experience report (PADER), U.S. periodic adverse experience report (PAER), or ICH E2C Periodic Safety Update Report (PSUR), to satisfy the periodic postmarketing safety reporting requirements in §§ 314.80(c)(2) and 600.80(c)(2) (21 CFR 314.80(c)(2) and 600.80(c)(2)). This guidance also describes the procedures applicants should follow if they wish to submit a PBRER in place of a PADER, PAER, or PSUR. The steps will differ, depending on whether or not the applicant has an approved waiver in place to substitute the PSUR for the PADER/PAER.

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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-0349.

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