Drugs and biological therapeutics are commonly prescribed to pediatric patients in the absence of adequate dosage and administration information in the product label. This paper describes issues surrounding labeling of drugs and biologics for pediatric use. It includes a discussion of why drugs and biologics should be labeled with pediatric use information, an update on the status of regulatory guidance for pediatric labeling, and a summary of recent steps taken by the Food and Drug Administration (FDA) to increase the number of therapeutic products that contain appropriate labeling for pediatric use.
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