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Presenter outlines FDA risk-based review process for secondary DMFs
Summary
A presenter described how type 2 secondary Drug Master Files (DMFs)—used as starting materials, intermediates or APIs—affect the adequacy review of primary DMFs, documentation expectations and how deficiencies in secondary DMFs can delay approvals.
The presenter opened a technical briefing explaining the agency's risk-based regulatory review approach for secondary DMFs and their role in evaluating primary DMFs. “In this presentation, I'm going to discuss the risk based regulatory review process for the acceptance of type 2 secondary DMFs,” the presenter said.
The talk emphasized that reviewers evaluate a primary DMF’s manufacturing process and impurity-control strategy using information across both primary and any associated secondary DMFs and facilities. The presenter warned that when secondary DMFs are associated with a primary DMF, “the manufacturing process of the primary DMF drug substance is evaluated based on the information presented in all the DMFs that is primary and secondary DMFs, including facilities.” The presentation framed this cross-referencing as central to determining adequacy and potential next steps when information is missing.
