Oncology Drug Development and Approval of Systemic Anticancer Therapy by the U.S. Food and Drug Administration

BACKGROUND. Regulatory approval of oncology drugs is the cornerstone of the development process and approval characteristics shape eventual utilization. Approval trends and characteristics provide valuable information for drug developers and regulators and ultimately affect clinicians and patients....

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Hlavní autoři: Martell, Robert E., Sermer, David, Getz, Kenneth, Kaitin, Kenneth I.
Médium: Artigo
Jazyk:Inglês
Vydáno: AlphaMed Press 2013
Témata:
Regulatory Issues: FDA
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC3556246/
https://ncbi.nlm.nih.gov/pubmed/23263289
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1634/theoncologist.2012-0235
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