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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Detalhes bibliográficos
Main Authors: Chan, John K., Kiet, Tuyen K., Monk, Bradley J., Young-Lin, Nichole, Blansit, Kevin, Kapp, Daniel S., Amanam, Idoroenyi
Formato: Artigo
Idioma:Inglês
Publicado em: AlphaMed Press 2014
Assuntos:
Regulatory Issues: FDA
Acesso em linha: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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