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Making medications safer for newborns

(Wiley) Although new drugs must be shown to be both safe and effective for approval by the Food and Drug Administration, sick newborns receive most of their drug treatment off-label and without the evidence provided for adults and older children. A new editorial looks at the challenges of performing clinical trials in newborns, from the reluctance of parents to enroll their infants to the lack of experience of pediatricians and neonatologists in conducting clinical research.
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