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BLA Content Requirements: Field Copy Certification and Study Data Standardization Plan?

  • 1.  BLA Content Requirements: Field Copy Certification and Study Data Standardization Plan?

    This message was posted by a user wishing to remain anonymous
    Posted 05-Oct-2023 07:10
    This message was posted by a user wishing to remain anonymous

    Dear Colleagues,

    Are any of the following required content in an original BLA?:

    • Field copy certification
    • Study data standardization plan
    • Transfer of regulatory obligations document(s)...besides that which is included in BIMO content in Module 5

    Thank you for your input.



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