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GUIDANCE DOCUMENT

E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) July 2016

Download the Final Guidance Document
Final
Docket Number:
FDA-2012-D-0315
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

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.
 

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All written comments should be identified with this document's docket number: FDA-2012-D-0315.

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