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

• Main Authors: Ulrich‐P. Rohr (Author), Mario Iovino (Author), Leonie Rudofsky (Author), Qiyu Li (Author), Stephanie Juritz (Author), Arunas Gircys (Author), Oliver Wildner (Author), Magda Bujar (Author), Claus Bolte (Author), Simon Dalla Torre di Sanguinetto (Author), Anita Wolfer (Author)
• Format: Book
• Published: Wiley, 2023-09-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...