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# FDA Issues Pediatric Guidance Addendum
- URL: https://www.fdaweb.com/fda-issues-pediatric-guidance-addendum/
- Published: 2018-04-10T12:00:00.000Z
- Updated: 2026-09-14T23:58:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141185

FDA has published an International Conference on Harmonization addendum, *Clinical Investigation of Medicinal Products in the Pediatric Population*, to consider regulatory and scientific advances relevant to pediatric populations that have evolved since the 2000 publication of the original guidance. The [addendum](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM530012.pdf?ref=fdaweb.com) does not alter the scope of the original guidance but rather is to complement and provide clarification and current regulatory perspective on topics in pediatric drug development.

The document covers ethical considerations, commonality of scientific approach for pediatric drug development programs, age classification and pediatric subgroups including neonates, approaches to optimize pediatric drug development, practicalities in the design and execution of pediatric clinical trials, and pediatric formulations.