Editor’s note: This is the fourth of 12 articles from the Food and Drug Administration (FDA) highlighting some of the 500 products that have received new pediatric labeling information since 1998. This summary includes products that have been studied and have neonatal information in labeling and some of the issues that occur when trying to define appropriate neonatal dosing and endpoints.

Clinical studies that lead to safety, efficacy and dosing information for drugs used in neonates are critical. Trials in this population are sparse, however, due to multiple scientific and regulatory challenges. Rapid physiological changes in the developing neonate impact study design and endpoints. Study designs and procedures that are appropriate in adults and older children may not be appropriate in neonates. In addition, appropriate formulations for use in neonates may not exist. Furthermore, neonatal studies include significant blood sampling limitations.

Despite these challenges, 28 labeling changes have been made...

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