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  • 1.  Drug Master File

    This message was posted by a user wishing to remain anonymous
    Posted 15-May-2018 08:48
    This message was posted by a user wishing to remain anonymous

    While submitted new information to a DMF, for e.g. update to 3.2.S.4.1, does a tracked changes copy need to be included in the FDA submission?

    Thanks,
    Anon


  • 2.  RE: Drug Master File

    Posted 16-May-2018 12:06

    No. A Track Changes version is not required. The cover letter to your DMF Amendment should list all Mod 3 sections that are being updated. It's been a while since I made a DMF submission, but I think we included a high level summary of the changes that were being made – possibly in the cover letter.  Also note, changes to a DMF should not be included in a DMF Annual Report – they should only be submitted in a DMF Amendment. 

    Tom

    Chicago




    Original Message


  • 3.  RE: Drug Master File

    Posted 16-May-2018 19:32
    Dear Anon,
    A track changes version does not need to be included in a DMF amendment.  However, a summary of any changes/new information should be included in the DMF submission.  A high level summary can be listed in the cover letter or, alternatively, include a summary of changes document in Module 1.11.1 Quality Information Amendment, or in Module 2.3 QOS.  The benefit of an eCTD DMF is you can clearly state where the summary of changes is within your DMF amendment and hyperlink directly to the document.
    Good luck!
    Bridgette

    ------------------------------
    Bridgette Kunst, MA, RAC
    Managing Director
    Bridge Regulatory Affairs, LLC
    bkunst@bridgereg.com
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    Original Message


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