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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Dades bibliogràfiques
Publicat a:Oncologist
Autors principals: Blumenthal, Gideon M., Kluetz, Paul G., Schneider, Julie, Goldberg, Kirsten B., McKee, Amy E., Pazdur, Richard
Format: Artigo
Idioma:Inglês
Publicat: AlphaMed Press 2017
Matèries:
Commentaries
Accés en línia: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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