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  • 1.  Annual report for NDA

    This message was posted by a user wishing to remain anonymous
    Posted 07-May-2018 10:41
    This message was posted by a user wishing to remain anonymous

    Hi Folks,

    Could you please suggest how we can proceed our AR for NDA without annual GMP stability data? We didn't manufacture product last year because of unavailability of drug substance.

    Thank you,


  • 2.  RE: Annual report for NDA

    Posted 07-May-2018 10:55
    It is not mandatory that AR for NDA must contain annual GMP stability data. Just state the fact that you didn't manufacture product last year because of unavailability of drug substance and therefore no stability data. You can always submit later  to the NDA or even in the next AR

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    Original Message


  • 3.  RE: Annual report for NDA

    This message was posted by a user wishing to remain anonymous
    Posted 07-May-2018 17:51
    This message was posted by a user wishing to remain anonymous

    Thank you Narayan Rao!
    Original Message


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