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  • 1.  NDA CMC Supplement - Field Copy Certification

    Posted 11-Jul-2020 16:58
    Looking for insight on providing the FDA ORA District Office field copy notification that an eCTD NDA CMC supplement has been submitted...is it still required to send a hard copy or can the letter be sent via email?
    Thank you!


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    Bridgette Kunst MA, RAC
    Managing Director
    bkunst@bridgereg.com
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  • 2.  RE: NDA CMC Supplement - Field Copy Certification

    This message was posted by a user wishing to remain anonymous
    Posted 15-Jul-2020 16:25
    This message was posted by a user wishing to remain anonymous

    For the last 4 years, I have just sent an E-mail to the person at the field office. Once, I got a reply back that asked me to make sure to include the nonproprietary name since that information was inadvertently forgotten,
    Original Message


  • 3.  RE: NDA CMC Supplement - Field Copy Certification

    Posted 16-Jul-2020 09:47
    Great, thank you very much!

    ------------------------------
    Bridgette Kunst RAC, MA
    Managing Director
    bkunst@bridgereg.com
    ------------------------------

    Original Message


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