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Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration
IMPORTANCE: Drugs treating serious or life-threatening conditions can receive US Food and Drug Administration (FDA) accelerated approval based on showing an effect in surrogate measures that are only reasonably likely to predict clinical benefit. Confirmatory trials are then required to determine wh...
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| Udgivet i: | JAMA |
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| Main Authors: | , , |
| Format: | Artigo |
| Sprog: | Inglês |
| Udgivet: |
American Medical Association
2017
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| Fag: | |
| Online adgang: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5817559/ https://ncbi.nlm.nih.gov/pubmed/28810023 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jama.2017.9415 |
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