Applications for Oncologic Drugs: A Descriptive Analysis of the Oncologic Drugs Advisory Committee Reviews

BACKGROUND: Despite advances in cancer research, the majority of drug applications submitted to the U.S. Food and Drug Administration (FDA) are not approved. It is important to identify the concerns of the Oncologic Drugs Advisory Committee (ODAC) from rejected applications. METHODS: All application...

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Bibliografski detalji
Glavni autori: Chan, John K., Kiet, Tuyen K., Monk, Bradley J., Young-Lin, Nichole, Blansit, Kevin, Kapp, Daniel S., Amanam, Idoroenyi
Format: Artigo
Jezik:Inglês
Izdano: AlphaMed Press 2014
Teme:
Regulatory Issues: FDA
Online pristup:https://ncbi.nlm.nih.gov/pmc/articles/PMC3958455/
https://ncbi.nlm.nih.gov/pubmed/24599479
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1634/theoncologist.2013-0276
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