Advances in pediatric pharmacology, therapeutics, and toxicology.


Journal Article (Review)

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.

Full Text

Duke Authors

Cited Authors

  • Gonzalez, D; Paul, IM; Benjamin, DK; Cohen-Wolkowiez, M

Published Date

  • August 2014

Published In

Volume / Issue

  • 61 / 1

Start / End Page

  • 7 - 31

PubMed ID

  • 25037123

Pubmed Central ID

  • 25037123

Electronic International Standard Serial Number (EISSN)

  • 1878-1926

Digital Object Identifier (DOI)

  • 10.1016/j.yapd.2014.03.005


  • eng

Conference Location

  • United States