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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...

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Detalles Bibliográficos
Autores principales: Skydel, Joshua J., Egilman, Alexander C., Wallach, Joshua D., Ramachandran, Reshma, Gupta, Ravi, Ross, Joseph S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2022
Materias:
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