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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.