Safer, Better, More Appropriate: Clinical Trial Design for Pediatric Drug Labels (original) (raw)

Therapeutic Innovation & Regulatory Science, 2006

Abstract

Off-label use of drugs in pediatrics remains a national and international problem. The American Academy of Pediatrics determined in 1977, and reaffirmed in 1995, that there was a moral imperative to formally study drugs in children so they “have access to important medications and receive optimal drug therapy.” Congress passed legislation in 1997 that encouraged the study of patent drugs,

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