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Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation
This study used the Drugs@FDA database to review FDA-approved “breakthrough” therapies from 2012 to 2017 (characterizing the pivotal clinical trials that serve as the basis of FDA approval), and premarket development and review times to assess the strength of evidence supporting breakthrough approva...
Αποθηκεύτηκε σε:
| Τόπος έκδοσης: | JAMA |
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| Κύριοι συγγραφείς: | , , |
| Μορφή: | Artigo |
| Γλώσσα: | Inglês |
| Έκδοση: |
American Medical Association
2018
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| Θέματα: | |
| Διαθέσιμο Online: | https://ncbi.nlm.nih.gov/pmc/articles/PMC6583484/ https://ncbi.nlm.nih.gov/pubmed/30027239 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jama.2018.7619 |
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