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Presenter reiterates LOA and documentation expectations to avoid review delays
Summary
The presenter advised DMF holders to include letters of authorization (LOAs) and clearly document material sources, facility information and form/cover-letter references (e.g., form 3938, section 3.2.S.1) to prevent late identification of secondary DMF associations that can delay reviews.
The presenter outlined items checked during DMF completeness assessment and emphasized where information should appear in filings. “Deborah indicated letter of authorization from the secondary DMF folder should be provided in section 1.4,” the presenter said, and advised that material sources and facility information be clearly mentioned in appropriate sections.
The presenter also noted documentation practices reviewers look for—form 3938, cover letters and section 3.2.S.1 entries that document secondary DMF association—and warned that late identification of secondary DMF associations can lead to delays and issuance of IR (information request) letters. Where LOAs are feasible and confidentiality permits, presenters encouraged secondary DMF holders to provide LOAs authorizing product applicants to reference the secondary DMF directly to avoid missing facility information.
