Global Harmonization of Pediatric Drug Development: Critical for Progress for Developing Safe and Effective Therapeutic Agents for Children
- PMID: 31388364
- PMCID: PMC6677566
- DOI: 10.1016/j.curtheres.2019.01.006
Global Harmonization of Pediatric Drug Development: Critical for Progress for Developing Safe and Effective Therapeutic Agents for Children
Erratum in
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Erratum regarding missing Declaration of Competing Interest statements in previously published articles.Curr Ther Res Clin Exp. 2020 Dec 29;94:100622. doi: 10.1016/j.curtheres.2020.100622. eCollection 2021. Curr Ther Res Clin Exp. 2020. PMID: 34386108 Free PMC article.
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: BPCA; PIP; PREA; Pediatric drug development.
References
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- Stafford RS. Off-label use of drugs and medical devices: a review of policy implications. Clin Pharmacol Ther. 2012;91:920–925. - PubMed
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