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Expanded Access as a source of real‐world data: An overview of FDA and EMA approvals
AIMS: To identify, characterize and compare all Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals that included real‐world data on efficacy from expanded access (EA) programmes. METHODS: Cross‐sectional study of FDA (1955–2018) and EMA (1995–2018) regulatory approval d...
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| 出版年: | Br J Clin Pharmacol |
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| 主要な著者: | , , |
| フォーマット: | Artigo |
| 言語: | Inglês |
| 出版事項: |
John Wiley and Sons Inc.
2020
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| 主題: | |
| オンライン･アクセス: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7444779/ https://ncbi.nlm.nih.gov/pubmed/32200551 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/bcp.14284 |
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