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Module 1 Content for 351(a) BLA

  • 1.  Module 1 Content for 351(a) BLA

    This message was posted by a user wishing to remain anonymous
    Posted 13 days ago
    This message was posted by a user wishing to remain anonymous

    Dear Colleagues,

    Do the following eCTD sections apply for a 351(a) BLA?:

    • 1.3.2 Field Copy Certification
    • 1.3.5.3 Exclusivity Claim

    Thank you for your guidance!

     



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