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Regulation FDA United States

Updated DMF Guidance Reflects GDUFA II

Draft FDA Guidance Also Requires Electronic Submission

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Executive Summary

US FDA’s first revision of its foundational Drug Master Files guidance in 30 years contains few surprises but incorporates statutory and regulatory actions. Among the changes: a new section requiring electronic submission of DMFs and a section reflecting GDUFA II completeness assessments in Type II DMFs.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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