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  • 1.  Updating analytical method content in CMC amendment to IND

    This message was posted by a user wishing to remain anonymous
    Posted 23-Apr-2019 12:15
    This message was posted by a user wishing to remain anonymous

    Hello everyone, 

    The Module 3 of our IND (in eCDT format) has several historical drug substance (and product) lots that have been tested by different analytical methods to different specifications. We are now drafting a CMC amendment to report an update to the analytical method that could be applied to any of the lots, and will definitely be used for lots going forward. In this CMC amendment, would you:

    1) "Overwrite" the previous detailed Analytical Method description and Analytical Method Validation sections (replace old method information with new), since the previous versions of the IND have detailed the old method.
    or
    2) Just add the new information and retain the old, since the old method was used to test the old lots, which we still use for decision-making.

    I'm just hoping to report in a way that makes the history clear to the FDA reviewers. 

    Thanks very much for your recommendations!


  • 2.  RE: Updating analytical method content in CMC amendment to IND

    Posted 24-Apr-2019 14:43
    I would replace the old with the new method/validation.  The history will be there in the eCTD backbone.  During development, changes are made to methods, specifications, processes, etc and there is no need to keep all of that history in the current version of each IND section.  That's the beauty of eCTD - the history is always there.

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    Tom
    Senior Director, Regulatory Affairs CMC
    Chicago
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