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Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia

Regulatory agencies have sought to speed up the review of new cancer medicines and reduce delays in approval between countries. We examined trends in regulatory review times and association with clinical benefit for new cancer medicines in six jurisdictions: United States (Food and Drug Administrati...

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Detalles Bibliográficos
Autores principales: Hwang, Thomas J., Kesselheim, Aaron S., Tibau, Ariadna, Lee, ChangWon C., Vokinger, Kerstin N.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer Health 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9509186/
https://www.ncbi.nlm.nih.gov/pubmed/35731996
http://dx.doi.org/10.1200/OP.21.00909