Pediatric regulatory initiatives

Handb Exp Pharmacol. 2011;205:245-68. doi: 10.1007/978-3-642-20195-0_12.


A series of government actions have evolved since the 1990s to facilitate the development of medicinal products for pediatric use using a combination of incentives and mandates. The initiatives have been successful in stimulating activity and interest in products developed for pediatric use. The initiatives continue to evolve as experience accumulates and regulatory agencies develop robust cooperative programs. A multidimensional program is necessary to achieve the necessary goal of aligning pediatric therapeutics with adult therapeutics and providing children the most favorable opportunity to benefit and minimize risk to vulnerable populations.

Publication types

  • Historical Article

MeSH terms

  • Clinical Trials as Topic / legislation & jurisprudence
  • Clinical Trials as Topic / standards
  • Drug Approval / history
  • Drug Approval / legislation & jurisprudence*
  • Europe
  • History, 20th Century
  • History, 21st Century
  • Humans
  • International Cooperation
  • Legislation, Drug / history
  • Pediatrics / history
  • Pediatrics / legislation & jurisprudence*
  • Pharmacovigilance
  • United States
  • United States Food and Drug Administration