Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies

With the Breakthrough Therapy Designation program adding to the tools that the U.S. Food and Drug Administration (FDA) has for expediting drug development, the FDA reassessed the endpoints needed for approval of transformative therapies. Although the demonstration of an improvement in overall surviv...

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Vydáno v:Oncologist
Hlavní autoři: Blumenthal, Gideon M., Kluetz, Paul G., Schneider, Julie, Goldberg, Kirsten B., McKee, Amy E., Pazdur, Richard
Médium: Artigo
Jazyk:Inglês
Vydáno: AlphaMed Press 2017
Témata:
Commentaries
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC5507655/
https://ncbi.nlm.nih.gov/pubmed/28576856
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1634/theoncologist.2017-0152
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