Clinical development time is shorter for new anticancer drugs approved via accelerated approval in the US or via conditional approval in the EU

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) offer expedited regulatory approval programs for drugs with high potential patient value applicable at different stages leading to marketing authorization: (i) drug development (fast track designation (FTD), breakthrou...

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Detalles Bibliográficos
Autores principales: Demirci, Ebru, Omes‐Smit, Grace, Zwiers, Alex
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10339697/
https://www.ncbi.nlm.nih.gov/pubmed/37013379
http://dx.doi.org/10.1111/cts.13519

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10339697/
https://www.ncbi.nlm.nih.gov/pubmed/37013379
http://dx.doi.org/10.1111/cts.13519

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