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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...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
John Wiley and Sons Inc.
2022
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| Materias: | |
| 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 |