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# ICH Revised Guide on CTD Efficacy
- URL: https://www.fdaweb.com/ich-revised-guide-on-ctd-efficacy/
- Published: 2017-07-26T12:00:00.000Z
- Updated: 2026-09-14T22:36:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139229

*Federal Register* notice: FDA has announced the availability of a guidance on “M4E(R2): The CTD — Efficacy,” an International Council for Harmonization revised guidance that standardizes the presentation of benefit-risk information in regulatory submissions. It also provides greater specificity on the format and structure of benefit-risk information in submissions. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-07-25/pdf/2017-15534.pdf?ref=fdaweb.com).