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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...
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| Publicat a: | Open Forum Infect Dis |
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| Autors principals: | , |
| Format: | Artigo |
| Idioma: | Inglês |
| Publicat: |
Oxford University Press
2020
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| Matèries: | |
| Accés en línia: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7776201/ https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1093/ofid/ofaa439.1420 |
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