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AKTUALNOŚCI >> Mabion received a meeting minutes from the FDA after the meeting regarding the registration and marketing authorization process for MabionCD20 in the US

Mabion received a meeting minutes from the FDA after the meeting regarding the registration and marketing authorization process for MabionCD20 in the US

Following a Type 2 meeting with the US Food and Drug Administration (FDA, Agency) which took place on August 11, 2020, Mabion received on August 28 a meeting minutes of this meeting from the Agency. The summary confirms the possibility to use in the market authorization process of Mabion CD20 for the American market of a significant package of data from R&D process regarding the MabionCD20 product generated for the purposes of MA procedure in the European Union. This also confirms previous consultations with the FDA, in which the Agency did not indicate the reqirement to conduct a completely separate MabionCD20 development program in order to admit the drug to the US market.

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