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Pediatric Research: FDAs 2017 Adopted Version of ICH E11 Resulting in E11 (R1)

ICH E11 original and R1 both considerably changed the environment of drug development for children. They were written specifically to harmonize, promote, and facilitate high-quality and ethical clinical research for children within the ICH regions, i.e., the United States of America (USA), the European Union (EU), and Japan. In August 2017 several key topics within the E11 (R1) Addendum received new recommendations from the FDA. The scope of the 2000 policies, however, remains unchanged and still apply. In this discussion we will discuss E11 (R1) and the FDA issues pertaining to pediatric research. These topics included ethical considerations, age subgroups, pediatric formulations, and drug development research.


  • John Rowell, MSN, RN, CCRC, Director of Cancer Clinical Trials Office, LSU Health Shreveport