Abstract
Despite recent efforts by the US Food and Drug Administration (FDA) to improve the quality and quantity of clinical research data,1 two-thirds of drugs prescribed currently to children have not been studied for safety and efficacy in pediatric populations, and information on the efficacy and safety of drugs in children is not methodically collected and analyzed.2 According to some studies, the majority of pediatric drugs prescribed for children involve unlicensed drugs or off-label prescribing across all medication categories.3 There is evidence of a greater risk of a severe adverse drug reaction occurring in association with the off-label or unlicensed use of drugs in children.4
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