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# Comments on ICH Pediatric Extrapolation Guidance
- URL: https://www.fdaweb.com/comments-on-ich-pediatric-extrapolation-guidance/
- Published: 2022-11-01T12:00:00.000Z
- Updated: 2026-09-14T18:04:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153097

The Biotechnology Innovation Organization (BIO) says it appreciates that a draft guidance developed by the International Council for Harmonization (ICH) explains how pediatric extrapolation can be applied practically to support the safety and efficacy of a product in pediatric populations in a manner that will advance pediatric drug development globally. BIO’s comment letter [says](https://www.regulations.gov/comment/FDA-2022-D-1562-0005?ref=fdaweb.com) the draft guidance provides sponsors with clarity on how to develop a pediatric extrapolation concept during drug development, including categorizing what is known, what is assumed, and what is a gap in information. The association gives FDA its general comments on the use of pediatric extrapolation during drug development and specific and then line-by-line comments on the ICH draft.

Pharmaceutical Research and Manufacturers of America (PhRMA) [commends](https://www.regulations.gov/comment/FDA-2022-D-1562-0006?ref=fdaweb.com) the efforts of the ICH and FDA to facilitate harmonized methodologies and strategies to incorporate pediatric extrapolation into overall drug development plans. “We support development of the ICH E11A guidance and FDA’s efforts to speed access to new drugs for pediatric patients while reducing exposure of pediatric populations to unnecessary clinical trials,” it says. The letter points to several important topics and issues that PhRMA says are not addressed in the draft and provides specific and line-by-line comments.