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# ICH Addendum to Pediatric Trial Guide
- URL: https://www.fdaweb.com/ich-addendum-to-pediatric-trial-guide/
- Published: 2018-04-12T12:00:00.000Z
- Updated: 2026-09-14T23:58:51.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141203

*Federal Register* notice: FDA has made available a guidance entitled “E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population.” The International Council for Harmonization addendum provides updates to the original 2000 guidance and it does not alter the scope of the original guidance, which outlines an approach to the safe, efficient, and ethical study of medicinal products in the pediatric population. The addendum also provides clarification and current regulatory perspective on topics in pediatric drug development. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-04-11/pdf/2018-07375.pdf?ref=fdaweb.com).