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Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017
IMPORTANCE: Accelerated approval by the US Food and Drug Administration (FDA) grants market authorization for drugs based on clinical trials using surrogate end points likely to anticipate a clinical benefit. The FDA requires postapproval trials to confirm benefit, after which the accelerated approv...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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American Medical Association
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9142876/ https://www.ncbi.nlm.nih.gov/pubmed/35977252 http://dx.doi.org/10.1001/jamahealthforum.2022.1158 |