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....