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  • 1.  Referencing information in an IND that has been made inactive

    Posted 31-May-2019 10:57
    Hello everyone, 

    Is it possible to continue cross-referencing to information contained in an IND that has been made inactive?

    If said IND was the parent IND for nonclinical/clinical or CMC information, but deveIopment for that indication will be discontinued, I assume just before that IND is terminated (after 5 years in active status), that the information could be migrated to another IND for the product/program?

    I look forward to hearing from you.

    ------------------------------
    Laura Morley
    Senior Regulatory Affairs Associate CMC
    Foster City CA
    United States
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  • 2.  RE: Referencing information in an IND that has been made inactive

    Posted 03-Jun-2019 11:23
    Hi Laura,
    It is acceptable to cross-reference information in an inactive IND (see 21 CFR 312.45).  Please note that if the IND is withdrawn, then it is not possible to cross-reference the information.

    As long as the sponsor is the same, the information could be migrated to the new active IND.

    Good luck!
    Bridgette

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


  • 3.  RE: Referencing information in an IND that has been made inactive

    Posted 03-Jun-2019 12:20
    Hi Bridgette, 

    That's great - I appreciate you taking the time to respond.

    ------------------------------
    Laura Morley
    Senior Regulatory Affairs Associate CMC
    Foster City CA
    United States
    ------------------------------

    Original Message


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