A decade comparison of regulatory decision patterns for oncology products to all other non‐oncology products among Swissmedic, European Medicines Agency, and US Food and Drug Administration

Consensus of regulatory decisions on the same Marketing Authorization Application (MAA) are critical for stakeholders. In this context, regulatory decision patterns from the Swissmedic (SMC), the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA) were analyzed for hemato‐...

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Detalles Bibliográficos
Autores principales: Rohr, Ulrich‐P., Iovino, Mario, Rudofsky, Leonie, Li, Qiyu, Juritz, Stephanie, Gircys, Arunas, Wildner, Oliver, Bujar, Magda, Bolte, Claus, Dalla Torre di Sanguinetto, Simon, Wolfer, Anita
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/PMC10499418/
https://www.ncbi.nlm.nih.gov/pubmed/37408165
http://dx.doi.org/10.1111/cts.13567

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