Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US.

ABSTRACT: Pediatric legislations in the European Union (EU) and the United States (US) have increased medicines approved for use in the pediatric population. Despite many similarities between these frameworks, the EU Paediatric Regulation more often provides regulators with a mandate to require pediatric drug development for novel medicinal products compared to US regulators. If used, this could give rise to differences in the guidance for pediatric use provided for clinicians in the two regions. However, the level of discordance in the guidance for pediatric use between the two regions is unknown. This cross-sectional study compares guidance for pediatric use in the EU Summary of Product Characteristics (SmPC) and the US Prescription Information (USPI) on the level of indications granted for novel

SUBMITTER: Christiansen H 

PROVIDER: S-EPMC8979467 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature