Global Harmonization of Pediatric Drug Development: Critical for Progress for Developing Safe and Effective Therapeutic Agents for Children

Andrew E. Mulberg, MD, FAAP; Timothy Cripps, MSc

Current Therapeutic Research (Jan 2019)

Global Harmonization of Pediatric Drug Development: Critical for Progress for Developing Safe and Effective Therapeutic Agents for Children

Andrew E. Mulberg, MD, FAAP,
Timothy Cripps, MSc

Affiliations

Andrew E. Mulberg, MD, FAAP: Address correspondence to: Andrew E. Mulberg, MD, FAAP, Global Regulatory Affairs, Amicus Therapeutics Inc, 1 Cedar Brook Dr, Cranbury, NJ 08512.; Amicus Therapeutics Inc, Cranbury, NJ
Timothy Cripps, MSc: Amicus Therapeutics Inc, Cranbury, NJ

Journal volume & issue: Vol. 90
pp. 109 – 112

Abstract

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ABSTRACT: The article, ''Questionable Industry-Sponsored Studies in Children and Adolescents in Slovenia'' provides an opportunity to discuss evolving US and EU legislative measures to improve the available clinical trial-derived pediatric data and provide coherent labeling for pediatric providers in dosing of drugs for children. Keywords: Pediatric drug development, PIP, BPCA, PREA

Published in Current Therapeutic Research

ISSN: 0011-393X (Print); 1879-0313 (Online)
Publisher: Elsevier
Country of publisher: Netherlands
LCC subjects: Medicine: Therapeutics. Pharmacology
Website: http://www.journals.elsevier.com/current-therapeutic-research/

About the journal