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Medical News and Perspectives
January 28, 2004

Pediatric Drug Studies Required by Law

JAMA. 2004;291(4):412-413. doi:10.1001/jama.291.4.412

Although medications for children have lined pharmacy shelves for years, it was only last month that a mandate for pediatric studies of drugs was signed into law. Congress and the Bush administration have now given the Food and Drug Administration (FDA) the power to require drug companies to conduct pediatric clinical trials on medications used by children.

"That is the key—they can't think of children as an afterthought. If they anticipate the product will be used in children, they need to think about how they will test it in children—early on," said Dianne Murphy, MD, director of the Office of Pediatric Therapeutics at the FDA.

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