US Importation and Use of Comparators

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December 12, 2022

US Importation and Use of Comparators

Hi all,

Is it possible to use a version of a comparator in the US that does not have FDA commercial approval? There is US-approved version as well as ex-US approved version. The sIMP would be written to allow this.

The problem I am trying to solve is to centrally pack/label all comparators in one location, rather than buy a US version and ex-US version.

I appreciate any insights.

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