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 biologies for pediatric use. It includes a discussion of why drugs and biologies 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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Shacter, E., DeSantis, P.L. Labeling of Drug and Biologic Products for Pediatric Use. Ther Innov Regul Sci 32, 299–303 (1998) doi:10.1177/009286159803200140