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FDA Says DMF Filings Held Up by Inadequate Information on Starting Materials

This article was originally published in The Gold Sheet

Executive Summary

FDA officials say that only 14 percent of Type II drug master file completeness assessments are being approved in the first review cycle and urged industry to meet with them via the 10-day teleconference to resolve issues early on. Inadequate information on starting materials is a major deficiency and one of the most intractable problems found in API DMF filings, they say.

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