Children sadly have been excluded from some of the therapeutic advances that have marked pharmaceutical drug development during the past 100 years. Most drugs in use today lack Food and Drug Administration approval for use in children or are restricted to certain pediatric age groups, predominately older than 12 years. Only a few of the new drugs approved each year have pediatric indications and dosing guidelines described in the drug labeling information. However, many of these drugs are used in children. The lack of suitable information places children at risk for over- or underdosing, and there is a lack of suitable dosage forms, which can result in improper drug administration. This lack of information on the safe and effective use of drugs in the most vulnerable patients—infants and neonates—is of greatest concern. Recent changes in the regulations that govern drug development has dramatically increased the number of drugs that undergo testing in children. This article reviews new laws that govern drug testing in children and the use of children in therapeutic research.

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