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Presenter stresses early facility information and LOAs to avoid inspection and timeline delays
Summary
The presenter emphasized that facility information and cGMP statements for secondary DMF sources should be included early (in section 3/3.2.S.1) and that secondary DMF holders are encouraged to provide LOAs to applicants where confidentiality allows, citing FDA draft guidance on incorporating secondary DMF information by reference.
The presenter emphasized the importance of identifying facility information and cGMP compliance early in submissions so that facility evaluations can be scheduled in a timely manner. “Having the correct facility information early in the application is critical for timely evaluation of secondary DMF facilities as needed,” the presenter said, and noted that late facility identification can delay approvals.
Citing FDA draft guidance, the presenter also encouraged secondary DMF holders—where confidentiality agreements permit—to submit LOAs authorizing product applicants to reference the secondary DMF directly so facility information is not missed. The presenter said that secondary DMFs are reviewed under the same target dates as primary DMFs and that unsolicited amendments to secondary DMFs can require extension of a primary DMF’s goal date.
