> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# 2 ICH Guidances on Periodic Benefit-Risk Evaluation
- URL: https://www.fdaweb.com/2-ich-guidances-on-periodic-benefit-risk-evaluation/
- Published: 2016-07-19T12:00:00.000Z
- Updated: 2026-09-14T21:15:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136227

*Federal Register* Notice: FDA is making available two guidances for industry entitled *E2C(R2) Periodic Benefit-Risk Evaluation (E2C(R2) guidance) and E2C(R2) Periodic Benefit-Risk Evaluation Report — Questions and Answers (E2C(R2) Q&A guidance).* These guidances were prepared under the auspices of the International Council for Harmonization (ICH). The E2C(R2) draft guidance, issued 4/11/12, updated and combined two ICH guidances, E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (E2C guidance) and Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (addendum to the E2C guidance). The E2C(R2) guidance is intended to describe the format, content, and timing of a Periodic Benefit-Risk Evaluation Report for an approved drug or biologic, and it finalizes the draft guidance. The E2C(R2) Q&A guidance is a supplementary guidance that is intended to clarify key issues in the E2C(R2) guidance. To download the E2C(R2) guidance, click [here.](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM299513.pdf?ref=fdaweb.com) To download the E2C(R2) Q&A guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM511567.pdf?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-07-19/pdf/2016-17009.pdf?ref=fdaweb.com)