Trends in paediatric clinical pharmacology data in US pharmaceutical labelling

BACKGROUND: There is often a lack of safety and efficacy data in the paediatric population at the time of drug approval. Legislative efforts have promoted clinical pharmacology research in this underserved population. We sought to determine the quantity and quality of paediatric clinical pharmacology data in US drug labelling at the time of initial approval and to evaluate trends over time. MATERIALS AND METHODS: The labelling data of 213 new …