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2025 FDA Financial Public Meeting
*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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*The opinions expressed by the hosts and guests in this show are not necessarily the views of Children’s Health Defense.
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):
