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FDA recommends FATE/PURGE discussion and consideration of maximum daily dose for impurity limits
Summary
Agency official urged DMF submitters to include FATE and PURGE discussions with data for organic impurities and to provide maximum daily dose information from referencing labels because impurity limits depend on dose guidance under ICH Q3A and ICH M7.
The presenter said when addressing organic impurities, DMF holders should provide a FATE and PURGE discussion supported by data so the agency understands the rationale for impurity control strategies. She recommended referencing documents such as ICH Q3A, ICH M7, USP monographs and the agency's nitrosamines guidance.
She also advised including maximum daily dose information drawn from labeling of the referencing drug products because impurity limits are calculated relative to dose under ICH Q3A and ICH M7; she pointed participants to a complementary talk by Melanie Mueller for more detail on dose determination.
