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FDA staff: group control correspondence by discipline; DMF-specific questions usually not answered directly
Summary
Panelists advised that controlled correspondence should be discipline-specific so it can be routed appropriately; Christina Marshall said the office generally does not answer DMF-specific questions but can address general questions that apply to multiple ANDAs and recommended the generic drugs mailbox for specific referrals.
Adam from Apotex asked whether there are limits on the number of deficiencies that can be addressed in a post-complete-response-letter controlled correspondence. Lieutenant Commander Fields answered there is no set numeric limit but recommended that companies group questions by the relevant discipline (for example, bioequivalence issues to the BE office) so the inquiry can be routed properly.
On questions about Drug Master Files (DMFs), Christina Marshall said the office generally does not handle DMF-specific technical questions. "We usually do not answer DMF questions," she said, but added that the office can accept general questions that concern multiple ANDAs and recommended submitting unclear or specific questions to the generic drugs mailbox for referral. The panel's guidance emphasized routing and discipline-specific framing to improve timeliness and clarity.
