A comparative review of marketing authorisation decisions in Switzerland, the EU, and the USA

19 April 2018 - In this study we compared Swissmedic’s regulatory marketing authorisation decisions to those of the US FDA ...

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Swissmedic updates biosimilar guidance to allow comparators of US origin

11 January 2018 - The Swiss Agency for Therapeutic Products (Swissmedic) has liberalized its rules on the comparators used in ...

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