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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Dettagli Bibliografici
Pubblicato in:Oncologist
Autori principali: Blumenthal, Gideon M., Kluetz, Paul G., Schneider, Julie, Goldberg, Kirsten B., McKee, Amy E., Pazdur, Richard
Natura: Artigo
Lingua:Inglês
Pubblicazione: AlphaMed Press 2017
Soggetti:
Commentaries
Accesso online: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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