Advances in pediatric pharmacology, therapeutics, and toxicology

Adv Pediatr. 2014 Aug;61(1):7-31. doi: 10.1016/j.yapd.2014.03.005. Epub 2014 May 6.

Abstract

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.

Keywords: Pediatrics; Pharmacokinetics; Pharmacology; Toxicology.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Research Support, U.S. Gov't, P.H.S.
  • Review

MeSH terms

  • Biomedical Research / trends*
  • Child
  • Disease Management*
  • Europe
  • Humans
  • Pediatrics / trends*
  • Pharmacology, Clinical / trends*
  • Toxicology / trends*
  • United States