The Food and Drug Administration (FDA or the Agency) is announcing an 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 VI, BsUFA II, and GDUFA II. These user fee programs were reauthorized as part of the Food and Drug Administration Reauthorization Act of 2017 (FDARA) signed by the President on August 18, 2017. The complete set of performance goals for each program are available at:
This meeting will provide FDA the opportunity to update interested public stakeholders on topics related to the financial management of PDUFA VI, BsUFA II, and GDUFA II. 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, modernizing its time reporting approach, and addressing the findings from the independent 3rd party evaluation of the resource management associated with PDUFA, BsUFA, and GDUFA that concluded and was published in FY 2019.
This year’s public meeting will take place remotely on June 18, 2021 from 9:30 a.m to 11:30 a.m
Federal Register Notice
Date and Location
June 18, 2021
9:30 – 11:30 AM EST.
The meeting will be held virtually by webcast.