E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers July 2016
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Drug 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.
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:
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-2012-D-0315.