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  • 1.  505 or PHS Act Section 351

    Posted 15-Oct-2021 23:52
    Good Morning Respected Peers of Community,
    Case study:
    The applicant have NME  Hormone with indication to control diabetes. Should applicant apply for 505 or PHS Act 351 as Biologics law is effective?
    Thanking you in anticipation.
    Regards.
    Monaz

    ------------------------------
    [Monaz] [Mysorewala] [M.Sc., DABT, ERT]
    [Manager]
    [SPARCL]
    [Vadodara] [Gujarat]
    [India][monazmysorewala@outlook.com][+91 9979118085]
    ------------------------------


  • 2.  RE: 505 or PHS Act Section 351

    This message was posted by a user wishing to remain anonymous
    Posted 17-Oct-2021 20:45
    This message was posted by a user wishing to remain anonymous

    505!
    Original Message


  • 3.  RE: 505 or PHS Act Section 351

    Posted 18-Oct-2021 01:46
    Hi, thank you for reply. I am wondering because PHS law explicit mentions that Biologics will be covered as BLA after 23 March 2020. May you please elaborate why 505 will be applicable? Thanking you in anticipation. Regards.

    ------------------------------
    [Monaz] [Mysorewala] [M.Sc., DABT, ERT]
    [Manager]
    [SPARCL]
    [Vadodara] [Gujarat]
    [India][monazmysorewala@outlook.com][+91 9979118085]
    ------------------------------

    Original Message


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