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# ICH Pediatric Extrapolation Guidance
- URL: https://www.fdaweb.com/ich-pediatric-extrapolation-guidance/
- Published: 2024-08-21T12:00:00.000Z
- Updated: 2026-09-14T14:39:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157624

FDA has published an International Council for Harmonization guidance, *E11A Pediatric Extrapolation*, to provide recommendations for and promote international harmonization of the use of pediatric extrapolation to support the development and authorization of pediatric medicines. The [document](https://database.ich.org/sites/default/files/ICH%5FE11A%5FGuideline%5FStep4%5F2024%5F0821.pdf?ref=fdaweb.com) says harmonization of the approaches to pediatric extrapolation should reduce the likelihood of substantial differences between regions.

“Importantly,” it says, “harmonization should also reduce exposure of pediatric populations to unnecessary clinical trials and facilitate more timely access to pediatric medicines globally.”

The guidance includes an Introduction, Pediatric Extrapolation Framework, Pediatric Extrapolation Concept, and Pediatric Extrapolation Plan.