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IVA/Promotional material submission

  • 1.  IVA/Promotional material submission

    Posted 12-Oct-2019 20:03
     Hi, 

    I have an really important question.
    We have submitted previously (one month ago) IVA with 2253 form. We got update from the FDA to make a change to previously submitted IVA.  I believe we only need to submit the one screen that changed and note this on 2253.  

    Can anyone give me feedback and let me know am I right?
    Any guidance that specifically talk about IVA and changes on the previously submitted promotional materials?

    I really appreciate your response, 

    Thanks,

    Masa 



    Maša Razić
    Regulatory Affairs Specialist
    m:339.223.7784 I masa.razic@partnertx.com 
    PARTNER THERAPEUTICS



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