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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...
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| Publicado no: | JAMA |
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| Main Authors: | , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
American Medical Association
2018
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| Assuntos: | |
| Acesso em linha: | 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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