Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012–2018

Despite legislation incentivizing and requiring drug companies to conduct pediatric clinical trials, there still is a 9-year delay in drug approval for pediatric labeling after the initial adult drug approval. The aim of this study was to review the experience of the US Food & Drug Administratio...

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Udgivet i:Clin Pharmacol Ther
Main Authors: Tanaudommongkon, Irin, Miyagi, Shogo John, Green, Dionna J., Burnham, Janelle M., van den Anker, John N., Park, Kyunghun, Wu, Johanna, McCune, Susan K., Yao, Lynne, Burckart, Gilbert J.
Format: Artigo
Sprog:Inglês
Udgivet: 2020
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Article
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC7572516/
https://ncbi.nlm.nih.gov/pubmed/32394430
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/cpt.1886
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