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, 2023 Fee as of April 1, 2024
1 New Master File Registration $1,351 $1,379
2 Update $587 $599
3 Letter of Access $192 $196

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

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