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Developing Standards for Breakthrough Therapy Designation in Oncology

In July 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA). The Advancing Breakthrough Therapies for Patients Act was incorporated into a Title of FDASIA to expedite clinical development of new, potential “breakthrough” drugs or treatments that show dramatic re...

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Detalhes bibliográficos
Main Authors: Horning, Sandra J., Haber, Daniel A., Selig, Wendy K.D., Ivy, S. Percy, Roberts, Samantha A., Allen, Jeff D., Sigal, Ellen V., Sawyers, Charles L.
Formato: Artigo
Idioma:Inglês
Publicado em: 2013
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3745545/
https://ncbi.nlm.nih.gov/pubmed/23719260
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1158/1078-0432.CCR-13-0523
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