2023 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments June 8, 2023

Meeting | Virtual

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• Date: June 8, 2023
• Time: 9:30 AM - 10:30 AM ET

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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
• BsUFA III program
• GDUFA III program

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 and modernizing its time reporting approach.

This year’s public meeting will take place remotely on June 8, 2023, from 9:30 AM to 10:30 AM Eastern Time.

Docket No. FDA-2019-N-1875

The Federal Register Notice announcing the meeting can be found here.

2023 Meeting Materials

• Agenda
• Presentation
• Recording/Transcript

Date and Location

June 8, 2023

9:30 AM – 10:30 AM ET

The meeting will be held virtually by webcast.

Past Meeting Materials

• 2022 Materials
  • Agenda
  • Presentation
  • Meeting Recording
  • Audio Transcript
• 2021 Materials
  • 2021 Agenda
  • 2021 Presentation
  • 2021 Webcast Recording - Passcode: &7UNVA%8
  • 2021 Transcript

Registration

Please register to attend the event via webcast. If you need special accommodations, please indicate this during registration or contact Monica Ellerbe at ofbapbusinessmanagementservices@fda.hhs.gov by June 5, 2023, at 11:59 PM Eastern Time.

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Event Materials

Title	File Type/Size
2023 FDA Public Meeting Agenda	pdf (105.93 KB)
2023 FDA Public Meeting Presentation	pdf (406.11 KB)