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Federal laws that motivate or require drug and biologic developers to conduct pediatric studies have yielded beneficial information to guide the use of medications in children, says a new report by the Institute of Medicine. Still, studies involving children continue to be limited, especially in certain areas such as medications' use in newborns and long-term safety and effectiveness in children.
Researching the safety and effectiveness of new drugs is more challenging in children than adults. Congress sought to boost studies involving pediatric patients by creating legislation that provides economic incentives and adds requirements for such research. Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, a new report from the Institute of Medicine, provides an independent assessment of several aspects of the studies carried out under this legislation, including the ethical challenges and the timeliness and usefulness of the clinical data that has been generated.