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  • 1.  BIMO for BLA CBER

    This message was posted by a user wishing to remain anonymous
    Posted 04-Nov-2022 15:14
    This message was posted by a user wishing to remain anonymous

    Does anyone know if BIMO information needs to be submitted for a new BLA under CBER?


  • 2.  RE: BIMO for BLA CBER

    Posted 05-Nov-2022 08:29
    Yes it does.


    Original Message


  • 3.  RE: BIMO for BLA CBER

    Posted 06-Nov-2022 01:03

    https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/bioresearch-monitoring-program-information

    Bioresearch Monitoring Program Information


    Good question! based on this link, it would appear that it is needed. But I don't have direct experience. 



    ------------------------------
    Lesley Pickford, PhD, MBA
    Senior BioPharma Partner
    Oceana Associates,
    Sebastopol CA
    United States
    lesley.pickford@oceana-associates.com
    ------------------------------

    Original Message


  • 4.  RE: BIMO for BLA CBER

    Posted 06-Nov-2022 18:02
    Yes, it is.  The point of BIMO is to ease in Inspections and frankly its a long time coming, required or not its good data to provide.

    ------------------------------
    Stephen Sullivan
    Director, Regulatory Operations
    Melrose MA
    United States
    ------------------------------

    Original Message


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