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Agency official stresses that letters of authorization are necessary for DMF review; Deborah Johnson to follow
Summary
The presenter said letters of authorization (LOAs) grant permission for another party to reference a DMF, noted LOAs are sometimes missing after completeness assessment, and announced a follow-up session by Deborah Johnson on LOA details.
The agency presenter said letters of authorization (LOAs) are essential for reviewers to evaluate referenced DMFs and urged submitters to keep LOAs updated. She described LOAs as documents that "give another party the right to reference your Drug Master file" and said missing LOAs often surface after completeness assessment, delaying review.
The presenter announced that Deborah Johnson will give a dedicated talk later in the session to provide more information on preparing and using LOAs. She recommended updating LOAs over time and including copies both in referencing ANDAs and in referenced DMFs.
