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eCTD section 5.3.1.4 (Reports of bioanalytical & analytical methods for human studies): content question

  • 1.  eCTD section 5.3.1.4 (Reports of bioanalytical & analytical methods for human studies): content question

    This message was posted by a user wishing to remain anonymous
    Posted 31-Jan-2024 09:11
    This message was posted by a user wishing to remain anonymous

    Colleagues,

    I am accustomed to including bioanalytical method validation reports in eCTD section 5.3.1.4 of an NDA or BLA.  However, I don't recall including reports of validated assay results in this section (at least, not in recent applications).

    Are reports of validated assay results required to be included in eCTD section 5.3.1.4?  If not, are there circumstances for which inclusion may be advisable in an NDA or BLA?

    Thank you for your guidance.



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