@inbook{bf829d31949143aab495574edca787ec,
title = "Pediatric regulatory initiatives",
abstract = "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.",
keywords = "Deferrals, European Pediatric Regulation, ICH E11 guidelines, Pediatric investigation plan, Pediatric medicines, Pediatric rules, Therapeutic orphans, United States Federal Pediatric Initiatives, Waivers, Written request",
author = "Steven Hirschfeld and Agnes Saint-Raymond",
year = "2011",
doi = "10.1007/978-3-642-20195-0_12",
language = "English",
isbn = "9783642201943",
series = "Handbook of Experimental Pharmacology",
pages = "245--268",
editor = "Hannsjorg Seyberth and Hannsjorg Seyberth and Matthias Schwab and Matthias Schwab and Anders Rane",
booktitle = "Pediatric Clinical Pharmacology",
}