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Neonatal Safety Information Reported to the FDA During Drug Development Studies

BACKGROUND: Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates is complicated by the unique nature of the po...

Disgrifiad llawn

Wedi'i Gadw mewn:
Manylion Llyfryddiaeth
Cyhoeddwyd yn:Ther Innov Regul Sci
Prif Awduron: Avant, Debbie, Baer, Gerri, Moore, Jason, Zheng, Panli, Sorbello, Alfred, Ariagno, Ron, Yao, Lynne, Burckart, Gilbert J., Wang, Jian
Fformat: Artigo
Iaith:Inglês
Cyhoeddwyd: 2017
Pynciau:
Mynediad Ar-lein:https://ncbi.nlm.nih.gov/pmc/articles/PMC5549935/
https://ncbi.nlm.nih.gov/pubmed/28804696
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/2168479017716713
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