Fees for Drug Master Files

Fees for the filing of Master File transactions used in support of drug submissions and DIN applications for human and/or veterinary use or Clinical Trial Applications (CTAs)
Item	Fee Category	Fee as of April 1, 2025	Fee as of April 1, 2026
1	New Master File Registration	$1,407	$1,436
2	Update	$611	$624
3	Letter of Access	$200	$204

Please visit the Fees for human drugs or Fees for veterinary drugs web page for relevant guidance documents and forms.

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2025-12-01