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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...
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| Publicado no: | Ther Innov Regul Sci |
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| Main Authors: | , , , , , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
2017
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| Assuntos: | |
| Acesso em linha: | 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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