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Panel urges precise Letters of Authorization when referencing parts of secondary DMFs
Summary
FDA panelists said LOAs should explicitly state which portions of a secondary DMF are being referenced so reviewers know what to assess; an overly broad LOA can make a primary DMF appear inadequate if unrelated portions of a secondary DMF have deficiencies.
Panelists at the FDA DMF roundtable urged applicants and DMF holders to make Letters of Authorization (LOAs) explicit about the portion of a secondary DMF being referenced so agency reviewers evaluate only the intended material. "If the LOA says we're only gonna go from point A to point C, that's what that secondary DMF would be reviewed for," a panelist said, underscoring that specificity helps avoid misapplied deficiencies.
Speakers illustrated the problem with intermediates that are part of an overall synthesis: if an LOA authorizes reference to an entire DMF but the applicant only uses an intermediate, reviewers may assume the entire DMF applies. "We allow company 8, we authorize them to reference from here to here," one panelist said as an example of a narrowly scoped LOA. The panel recommended DMF holders and applicants coordinate LOA language and submission routing so the chain of reference is clear to both the applicant and the agency.
