Výsledky vyhledávání - "Simon Dalla Torre di Sanguinetto"

Akademický článek

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

Autor: 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

Publikováno v: Clinical and Translational Science, Vol 16, Iss 9, Pp 1569-1581 (2023)

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 th

Externí odkaz: https://doaj.org/article/e184bbb2e2354aa0a3c679fb754bc3d4

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A Comparative Review of Marketing Authorization Decisions in Switzerland, the EU, and the USA

Autor: Simon Dalla Torre Di Sanguinetto, Janine Antonov, Claus Bolte, Esa Heinonen

Publikováno v: Therapeutic Innovation and Regulatory Science.

In this study we compared Swissmedic’s (SMC’s) regulatory marketing authorization decisions to those of the US Food and Drug Administration (FDA) and European drug regulatory authorities (EU). We investigated the overall similarity of the regulat

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ee9f709c9af1524ac98d0b439e68a4ef
http://juuli.fi/Record/0277684716

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