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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...
保存先:
| 出版年: | Open Forum Infect Dis |
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| 主要な著者: | , |
| フォーマット: | Artigo |
| 言語: | Inglês |
| 出版事項: |
Oxford University Press
2020
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| 主題: | |
| オンライン･アクセス: | 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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