Meeting | Virtual
Event Title
2024 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments
June 6, 2024
- Date:
- June 6, 2024
- Time:
- 9:30 a.m. - 10:40 a.m. ET
Description
The Food and Drug Administration (FDA or the Agency) is announcing its annual public meeting and opportunity for public comment on “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” This public meeting is intended to meet performance commitments included in PDUFA VII, BsUFA III, and GDUFA III. These user fee programs were reauthorized as part of the FDA User Fee Reauthorization Act of 2022 signed by the President on September 30, 2022. The complete set of performance goals for each program are available at:
- PDUFA VII Program (PDF - 452 KB)
- BsUFA III Program (PDF - 452 KB)
- GDUFA III Program (PDF - 295 KB)
This meeting will provide FDA the opportunity to update interested public stakeholders on topics related to the financial management of PDUFA VII, BsUFA III, and GDUFA III. This year, FDA will present the 5-year financial plans for each of these programs and update participants on the progress towards implementing resource capacity planning as part of fee setting and modernized time reporting.
This year’s public meeting will take place remotely on June 6, 2024, from 9:30 AM to 10:40 AM Eastern Time.
View the Federal Register Notice announcing the meeting.
2024 Meeting Materials
- Meeting Recording | Duration: 45m 31sec
- Presentation (PDF - 1 MB)
- Audio Transcript (PDF - 41 KB)
- Agenda (PDF - 129 KB)
Past Meeting Materials
2023 Materials
- Agenda (PDF - 105 KB)
- Presentation (PDF - 406 KB)
- Recording/Transcript | Duration: 23m 49sec
2022 Materials
- Agenda (PDF - 936 KB)
- Presentation (PDF - 936 KB)
- Meeting Recording | Duration: 53m 25sec
- Audio Transcript (PDF - 936 KB)
2021 Materials
- 2021 Agenda (PDF - 105 KB)
- 2021 Presentation (PDF - 3 MB)
- 2021 Webcast Recording - Passcode: &7UNVA%8
- 2021 Transcript (PDF - 936 KB)
Event Materials
| Title | File Type/Size |
|---|---|
| 2024 FDA Financial Public Meeting Agenda | pdf (129.98 KB) |
| 2024 FDA Financial Public Meeting Audio Transcript | pdf (41.59 KB) |
| 2024 FDA Financial Public Meeting Presentation | pdf (1.16 MB) |