Updated DMF Guidance Reflects GDUFA II

Draft FDA Guidance Also Requires Electronic Submission

31 Oct 2019

• By Joanne S. Eglovitch

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.

FDA's Draft DMF Revision Reflects New Laws And Policies • Source: Shutterstock

The US Food and Drug Administration has revised its guidance on Drug Master Files, its first in 30 years, and the new update reflects the statutory and regulatory actions since 1989 that affect DMF policy. For example, the revision adds a new section governing the electronic submissions of DMFs as well as a new section on Type II DMFs reflecting the Generic Drug User Fee Amendments of 2012.

GDUFA II requires Type II DMF holders to submit “completeness assessments” before reviews on abbreviated new drug applications can begin....

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