Regulations and Data Sources on Pediatric Clinical Studies in the United States and European Union


Pediatric studies of drugs and devices are warranted because of the heterogeneous physiological and psychological development and response to treatment between adults and children. However, most clinical studies are conducted in adults, which implies that many drugs and devices are used in the pediatric population without being adequately tested for efficacy and safety. Many regulatory agencies have imposed regulations and legislations aimed at filling this gap and incentivizing or requiring sponsors to conduct pediatric studies. This paper discusses several important definitions related to pediatric labeling and drug development, outlines the regulatory framework in the US and EU regarding pediatric studies, and presents several data sources suitable for study of pediatric labeling and pediatric studies.
Last updated on 01/03/2021