Abstract
A brief review of pediatric off-label prescribing reveals a need for remedial action. Real and presumed impediments to acquisition of clinical trial data in children are examined. Many impediments are found to lack substantive merit and fail to offer cause for not undertaking pediatric clinical trials. Recent legislative, and Food and Drug Administration (FDA) and National Institutes of Health (NIH) actions, offer remedial measures to increase labeling of drugs for children and thus decrease off-label prescribing prevalent for 30 years.
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