FDA Policy/General

FDA Posts User Fee Rates for FY 2027

FDA has published the following user fee rates for medical product programs for fiscal year (FY) 2027:

Prescription Drug User Fee Rates for FY 2027:

*** NDA/BLA requiring clinical data: $4,600,753 (FY 2026 $4,682,003)
*** NDA/BLA not requiring clinical data: $2,300,376 (FY 2026 $2,341,002)
*** Program Fee: $416,857 (FY 2026 $442,213)

For more information, see notice here.

Biosimilar User Fee Rates for FY 2027:

*** Biosimilar Application Requiring Clinical Data: $1,124,936 (FY 2026 $,1,200,794)
*** Biosimilar Application Not Requiring Clinical Data: $562,468 (FY 2026 $600,397)
*** Program Fee $195,887 (FY 2026 $209,097)

For more information, see notice here.

Generic Drug User Fee Rates for FY 2027:

Abbreviated New Drug Application (ANDA): $375,684 (FY 2026 $358,247)
Drug Master File (DMF): $109,899 (FY 2026 $102,584)
Program Fee -Large size operation: $1,927,291 (FY 2026 $1,918,377)
Program Fee - Medium size operation: $770,916 (FY 2026 $767,351)
Program Fee- Small business: $192,729 (FY 2026 $191,838)

For more information, see notice here.

Medical Device User Fee Rates for FY 2027:

510(k): $28,653 (FY 2026 $26,067)
PMA: $636,732 (FY 2026 $579,272)
De Novo: $191,020 (FY 2026 $173,782)

For more information, see notice here.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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