Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study

OBJECTIVE: To characterize the therapeutic value of new drugs approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and the association between these ratings and regulatory approval through expedited programs. DESIGN: Retrospective cohort study. SETTING: New drugs...

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Detalles Bibliográficos
Autores principales: Hwang, Thomas J, Ross, Joseph S, Vokinger, Kerstin N, Kesselheim, Aaron S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2020
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7537471/
https://www.ncbi.nlm.nih.gov/pubmed/33028575
http://dx.doi.org/10.1136/bmj.m3434

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7537471/
https://www.ncbi.nlm.nih.gov/pubmed/33028575
http://dx.doi.org/10.1136/bmj.m3434

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