2025 FDA Financial Public Meeting

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

‘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 (PDUFA), Biosimilar User Fee Act (BsUFA), and Generic Drug User Fee Amendments (GDUFA)”. 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.

‘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.’

Agenda (in Eastern Time):

9:30 AM – Begin Meeting (Kichelle Joseph, Director of Business Management Services Office of Finance, Budget, and Acquisitions)
9:32 AM – 9Welcome and Introduction (Benjamin Moncarz, Chief Financial Officer Office of Finance, Budget, and Acquisitions)
9:35 AM – Update on 5-Year Financial Plans (Olufunmilayo Ariyo, Director of User Fees Support Staff Office of Financial Management | Office of Finance, Budget, and Acquisitions)
9:55 AM – Independent Evaluation of the Resource Capacity Planning Capability (Valerie Overton, Ayesha Berlind, Senior Advisor & Project Manager Contractors | Eastern Research Group)
10:25 AM – Resource Capacity Planning Implementation Updates (Josh Barton, Director, Resource Capacity Planning Staff Office of Program and Strategic Analysis | Center for Drug Evaluation and Research)
10:35 AM – Wrap Up & Additional Information (Kichelle Joseph, Director of Business Management Services Office of Finance, Budget, and Acquisitions)

*The opinions expressed by the hosts and guests in this show are not necessarily the views of Children’s Health Defense.

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