Characteristics and Changes of Pediatric Therapeutic Trials under the Best Pharmaceuticals for Children Act

Before 1997, children were usually excluded from therapeutic trials for numerous reasons. Therefore, most drug and biological products lacked adequate pediatric information in labeling.1,2 The Best Pharmaceuticals for Children Act (BPCA)3 and the Pediatric Research Equity Act (PREA)4 use incentives and requirements, respectively, to address this gap, spurring pediatric drug research and development to inform new pediatric drug labeling by allowing the US Food and Drug Administration (FDA) to request and require studies.

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