Per the BsUFA II, GDUFA II, and PDUFA VI commitment letters, FDA will publish updates to the five-year plans no later than the second quarter of each fiscal year.

Biosimilar User Fees 

• BsUFA II Five-Year Financial Plan – 2021 update (PDF - 594KB)
• BsUFA II Five-Year Financial Plan – 2020 update (PDF - 1352KB)
• BsUFA II Five-Year Financial Plan – 2019 update (PDF - 544KB)
• BsUFA II Five-Year Financial Plan (PDF - 449KB)

Generic Drug User Fees

• GDUFA II Five-Year Financial Plan – 2021 update (PDF - 484KB)
• GDUFA II Five-Year Financial Plan – 2020 update (PDF - 436 KB)
• GDUFA II Five-Year Financial Plan – 2019 update (PDF - 418 KB)
• GDUFA II Five-Year Financial Plan (PDF - 366KB)

Prescription Drug User Fees

• PDUFA VI Five-Year Financial Plan – 2021 update (PDF - 596KB)
• PDUFA VI Five-Year Financial Plan – 2020 update (PDF - 1270KB)
• PDUFA VI Five-Year Financial Plan – 2019 update (PDF - 535KB)
• PDUFA VI Five-Year Financial Plan (PDF - 480KB)