Issue Date: July 18, 2016
Issued by: Center for Biologics Evaluation and Research
Topic(s): ICH-Efficacy
Status: Final
E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)
This guidance defines the recommended format and content of a Periodic Benefit-Risk Evaluation Report (PBRER), and provides an outline of points to be considered in the preparation and submission of the PBRER. The PBRER described in this guidance is intended to be a common standard for periodic benefit-risk evaluation reporting on marketed products (including approved drugs that are under further study) among the ICH regions.
Download the Guidance Document
