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Dermatol Ther. 2009 May-Jun;22(3):257-61. doi: 10.1111/j.1529-8019.2009.01239.x.

Drug therapy in pediatrics: a developing field.

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Office of New Drugs, FDA, Silver Spring, Maryland 20903, USA.


For many years, drug therapies were not explicitly studied in the pediatric population. The lack of data forced clinicians to treat children using empiric therapy, often guessing at the treatment dose. In addition to the lack of dosing information, there was no evidence that a product would be safe and efficacious in this unique population. Because dermatologic conditions are common in children, this lack of information affected dermatologists. In 1998, a new legislation passed that encouraged drug development in pediatrics. Additional legislation followed that allowed the Food and Drug Administration the authority to require studies in pediatrics when it was anticipated that a product would be used in the pediatric population. With the new legislation and a better understanding of differences in the dose effectiveness and safety profiles of drugs in children when compared with adults, evidence-based treatment of pediatric patients is now possible.

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