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US Food and Drug Administration Accelerated Approval Program for Nononcology Drug Indications Between 1992 and 2018

IMPORTANCE: The US Food and Drug Administration (FDA) grants accelerated approval according to surrogate measures of numerous drug indications for serious or life-threatening illnesses such as infectious diseases and cancer. Investigators, including the FDA, have evaluated the program’s regulatory a...

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Detalles Bibliográficos
Autores principales: Omae, Kenji, Onishi, Akira, Sahker, Ethan, Furukawa, Toshi A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9463606/
https://www.ncbi.nlm.nih.gov/pubmed/36083581
http://dx.doi.org/10.1001/jamanetworkopen.2022.30973