Advances in pediatric pharmacology, therapeutics, and toxicology.
In the United States, passage of the FDASIA legislation made BPCA and PREA permanent, no longer requiring reauthorization every 5 years. This landmark legislation also stressed the importance of performing clinical trials in neonates when appropriate. In Europe the Pediatric Regulation, which went into effect in early 2007, also provides a framework for expanding pediatric clinical research. Although much work remains, as a result of greater regulatory guidance more pediatric data are reaching product labels.
Gonzalez, D; Paul, IM; Benjamin, DK; Cohen-Wolkowiez, M
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