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• Clinical Trials of Drugs Used Off-Label in Neonates: Ethical Issues and Alternative Study Designs 

  Amin, Sanjiv B.; McDermott, Michael P.; Shamoo, Adil E. (2008-07)

  The use of drugs for indications unapproved by the Food and Drug Administration (FDA), often called "off label use, "is widespread in children, including neonates. The widespread off-label use of drugs in neonates presents ...