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Elsevier, Gofron, Krzysztof Ksawery, et al

The Team-NB has issued a position paper to explain how to assess if a change to a companion diagnostic device requires prior approval by a #NotifiedBody, and if that change triggers a new or follow-on consultation with the relevant national medicinal product authority and/or the European Medicines Agency

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doi: 10.31838/IJPR/2020.12.04.125 200

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The reason is limited scientific evidence and the fact that safety for the breastfed baby cant be confirmed