Exhibit 127 ยท Agency financial report
Financial Report to Congress, Prescription Drug User Fee Amendments, FY 2024
PDUFA user fees are not a fee for service. User fees are pooled and may be used for the allowable activities as defined in the FD&C Act.
FDA's statutory annual financial report on the PDUFA program. Table 11 (p. 16) gives user-fee obligations of $1,377,172,919 against total PDUFA program obligations of $1,772,198,497 in FY 2024, printed as 77 percent; the user-fee share was 73 percent in FY 2020, 74 in FY 2021, 76 in FY 2022 and 75 in FY 2023. Non-user-fee appropriations obligated for the program were $395,025,578, above the statutory spending trigger of $278,545,507 (p. 16). Fees are assessed on applications and annually on approved products, and are pooled (p. 5).
- Source
- U.S. Food and Drug Administration
- Date
- Fiscal year 2024 (1 October 2023 to 30 September 2024)
- Quoted from
- Report Overview, section C, p. 5
- Grade
- Primary record
- Document
- https://www.fda.gov/media/185331/download
- Accessed
- 2026-11-09
- Cited by
- Findings citing this exhibit
- Note
- Dividing the Table 11 dollar figures gives 77.7 percent; the report prints 77 percent. The denominator is the PDUFA human drug review program, not FDA's total budget.