The approach to anticancer drug development for children is evolving with a focus on mechanisms of action rather than adult indications, driven by new legislation such as the US FDA Reauthorization Act of 2017 and European regulatory updates. This shift necessitates prioritizing drug products due to the limited pediatric population and the vast number of adult drug products. The international multistakeholder organization ACCELERATE, in collaboration with the European Medicines Agency (EMA) and the FDA, has established Paediatric Strategy Forums to address these challenges and facilitate coordinated drug development efforts among stakeholders.
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Pearson, Andrew DJ, et al. "ACCELERATE Paediatric Strategy Forums: an advance for oncological drug development?." The Lancet Oncology 23.11 (2022): 1354-1357.
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