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DMF references for API under GDUFA III

  • 1.  DMF references for API under GDUFA III

    This message was posted by a user wishing to remain anonymous
    Posted 31-Mar-2023 08:25
    This message was posted by a user wishing to remain anonymous

    Hi,

    Under GDUFA, a DMF for an API needed to undergo a Completeness Assessment and have the DMF fee paid prior to being placed on the Available for Reference list.  The API DMF could only be referenced in an ANDA once it was on the Available list.  

    When GDUFA III was authorized, a new guidance was issued "Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA" (October 2022), but it makes no mention of the Completeness Assessment.  Does anyone have experience with this?  Is it replacing the CA, or is this process described in this guidance in addition to the Completeness Assessment?   

    I would appreciate your thoughts!