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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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Podrobná bibliografie
Hlavní autoři: 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.
Médium: Artigo
Jazyk:Inglês
Vydáno: 2013
Témata:
On-line přístup: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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