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GUIDANCE DOCUMENT

E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers July 2016

Final

E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers

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

The ICH guidance E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) is intended to be a common
standard for periodic benefit-risk evaluation reporting on marketed products among the ICH regions.
The ICH E2C(R2) guidance introduced new concepts linked to an evolution of the traditional
Periodic Safety Update Report (PSUR) from an interval safety report to a cumulative benefit-risk
report. It changed the focus from individual case safety reports to aggregate data evaluation.  In
addition, the broadened scope increased the need for integrating information within the report.
 


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.