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1235. On the Edge of Tomorrow: Expedited Regulatory Pathways for Anti-Infective Therapies
BACKGROUND: The FDA has developed expedited review programs and pathways to increase drug development for products that have a major clinical benefit. These programs include: Fast Track, Orphan Drug Status, Accelerated Approval, Priority Review, Breakthrough Therapy (BTD) and Qualified Infectious Di...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Oxford University Press
2020
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7776201/ http://dx.doi.org/10.1093/ofid/ofaa439.1420 |