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

07:00 EST 1st January 2018 | BioPortfolio

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

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 regulatory decisions, approval, and postmarketing withdrawal rates in the 3 jurisdictions. In case regulatory decisions diverged, we analyzed the reasons for rejection of marketing authorization applications (MAAs).

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This article was published in the following journal.

Name: Therapeutic innovation & regulatory science
ISSN: 2168-4804
Pages: 2168479018764660

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