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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Detalles Bibliográficos
Autores principales: Blumenthal, Gideon M., Kluetz, Paul G., Schneider, Julie, Goldberg, Kirsten B., McKee, Amy E., Pazdur, Richard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: AlphaMed Press 2017
Materias:
Commentaries
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5507655/
https://www.ncbi.nlm.nih.gov/pubmed/28576856
http://dx.doi.org/10.1634/theoncologist.2017-0152

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5507655/
https://www.ncbi.nlm.nih.gov/pubmed/28576856
http://dx.doi.org/10.1634/theoncologist.2017-0152

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