A detailed analysis of expedited regulatory review time of marketing authorization applications for new anticancer drugs in the US and EU

The aim of this study was to assess the effect of expedited regulatory approval programs used by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), type of product (small molecule or biotechnology‐derived product) and consulting scientific advisory committees on the r...

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Detalles Bibliográficos
Autores principales: da Costa Gonçalves, Fabiany, Demirci, Ebru, Zwiers, Alex
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9372420/
https://www.ncbi.nlm.nih.gov/pubmed/35561071
http://dx.doi.org/10.1111/cts.13308

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9372420/
https://www.ncbi.nlm.nih.gov/pubmed/35561071
http://dx.doi.org/10.1111/cts.13308

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