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The Best Pharmaceuticals for Children Act and Pediatric Research Equity Act reach the age of majority—An oncology perspective
Author(s) -
Bernhardt M. Brooke,
Lindsay Holly,
AllenRhoades Wendy,
Foster Jennifer H.
Publication year - 2021
Publication title -
pediatric blood and cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.116
H-Index - 105
eISSN - 1545-5017
pISSN - 1545-5009
DOI - 10.1002/pbc.28871
Subject(s) - medicine , pediatric oncology , dosing , equity (law) , drug labeling , perspective (graphical) , population , pediatric research , pediatric cancer , intensive care medicine , pediatrics , drug , pharmacology , cancer , environmental health , artificial intelligence , political science , computer science , law
The scarcity of adequate pediatric drug labeling information has long been problematic in the pediatric population, which may place children at risk for adverse drug effects. The ontogeny of infants, children, and adolescents over the course of the first two decades of life pose complex pharmacokinetic, dosing, administration, effectiveness, and toxicity‐related questions that require specific investigation. Here, we review the history that led to the passage of the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA), and provide commentary on issues relevant to pediatric oncology now and in the future.