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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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| Publicado no: | Oncologist |
|---|---|
| Main Authors: | , , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
AlphaMed Press
2017
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| Assuntos: | |
| Acesso em linha: | 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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