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# Draft Guide on Pediatric Clinical Trials
- URL: https://www.fdaweb.com/draft-guide-on-pediatric-clinical-trials/
- Published: 2016-11-22T12:00:00.000Z
- Updated: 2026-09-14T21:49:56.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137412

*Federal Register* Notice: FDA has made available a draft guidance entitled “E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population.” The International Council for Harmonization draft is intended to update the ICH E11 guidance and provide clarification and current regulatory perspective on topics in global pediatric drug development. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-11-22/pdf/2016-28048.pdf?ref=fdaweb.com).