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Secondary DMFs can derail reviews, FDA reviewer warns
Summary
Deborah Johnson described how secondary DMFs and missing LOAs create unexpected work for reviewers and can delay high-priority applications, urging firms to ensure LOAs are submitted to the correct DMF folder.
Johnson described a common operational problem when a primary DMF references a secondary DMF without a corresponding LOA in the secondary DMF. Reviewers may discover the dependency during a review and must issue information requests to obtain or direct LOAs to the correct DMF folder, which can consume critical review time.
She recounted a recent case where two DMFs supported a high-priority application amid a drug shortage; after finding a missing LOA the reviewers issued an information request and then had to confirm the LOA was submitted to the secondary DMF folder. The process "burned up 3 days on a clock that was less than 8 days," Johnson said, illustrating the potential for operational delay.
