Fees for Master Files for human drugs

Fees for the filing of Master File transactions used in support of drug submissions and DIN applications for human use or Clinical Trial Applications (CTAs)
Item Fee Category Fee as of April 1, 2022 Fee as of April 1, 2023
1 New Master File Registration $1,324 $1,351
2 Update $575 $587
3 Letter of Access $188 $192

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

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