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

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

Abstract 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 fo...

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Bibliographic Details
Main Authors: Ulrich‐P. Rohr, Mario Iovino, Leonie Rudofsky, Qiyu Li, Stephanie Juritz, Arunas Gircys, Oliver Wildner, Magda Bujar, Claus Bolte, Simon Dalla Torre di Sanguinetto, Anita Wolfer
Format: Article
Language:English
Published: Wiley 2023-09-01
Series:Clinical and Translational Science
Online Access:https://doi.org/10.1111/cts.13567

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