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# New Methods for Pediatric Drug Safety Workshop
- URL: https://www.fdaweb.com/new-methods-for-pediatric-drug-safety-workshop/
- Published: 2025-08-13T12:00:00.000Z
- Updated: 2026-09-14T15:18:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159676

FDA is announcing a 12/5 Public Workshop on “Pediatric Drug Development Safety and New Approach Methodologies” to discuss new approach methods that can address pediatric developmental safety during drug development.

FDA says the meeting comes at a critical time for pediatric drug development. “An accumulation of knowledge from pediatric drug development programs over the past 25 years provides information that should be used to improve the efficient development of safe and effective new drugs for children,” an agency notice says. At the same time, the use of juvenile animal testing for all pediatric preclinical assessments has led to a “limitations” realization for such assessments and the need to develop new approach methods for animal testing as expressed (see recent [FDA-NIH Workshop on Reducing Animal Testing](https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-nih-workshop-reducing-animal-testing-07072025?ref=fdaweb.com)), it adds.

The notice says the recent [ICH E11A Guidance on Pediatric Extrapolation](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e11a-pediatric-extrapolation?ref=fdaweb.com) has indicated that, under some conditions, safety can be extrapolated from the adult population to the pediatric patient population. “Since developmental drug toxicity is not evaluable in the adult population, additional methods must be identified that can answer the critical developmental safety questions raised in the [ICH E11A guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e11a-pediatric-extrapolation?ref=fdaweb.com),” it states.

[Learn more about the workshop here](https://trianglecersi.org/news/pediatric-developmental-safety-assessment-and-new-approach-methodologies-workshop-2?ref=fdaweb.com).