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Panel clarifies: DMFs are not required and secondary DMFs do not go through GDUFA completeness assessment
Summary
Panelists said DMFs are voluntary (not required), secondary DMFs need not pay completeness-assessment fees, and completeness assessments apply to type 2 DMFs submitted under GDUFA while drug-substance information in an application is assessed as part of filing review.
Panelists clarified that submission of a DMF is voluntary. "So, the DMF is never required," one panelist said, explaining that a primary DMF holder may choose whether to reference a secondary DMF. Panelists added that DMFs do not go through the same GDUFA completeness assessment process that applies to type 2 DMFs submitted under GDUFA commitments when drug-substance information is in an ANDA filing.
When asked whether a secondary DMF must pay a fee or undergo the completeness assessment if used in an ANDA, a panelist replied that the DMF does not go through the completeness assessment and that secondary DMFs do not need to pay that fee. Speakers recommended that applicants consult the GDUFA commitments and OPQ inquiries for definitive procedural questions.
