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  • 1.  505b2

    Posted 19-Jul-2019 05:36
    ​​Hi all, I am submitting a 505b2 relying on public  literature data for the non clinical study. Does AHFS (https://www.new.medicinescomplete.com) could be cited as referenced literature? or, considering that AHFS cites data obtained from commercial  product PI, I need to consider that product as a reference product?

    regards,
    Alessia

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    Alessia Vanzin
    Switzerland
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