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Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021
This cross-sectional study systematically characterizes the frequency of delayed confirmatory trials relative to deadlines set by the US Food and Drug Administration.
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Medical Association
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10066454/ https://www.ncbi.nlm.nih.gov/pubmed/37000434 http://dx.doi.org/10.1001/jamahealthforum.2023.0217 |