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 a public meeting and an 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:
- PDUFA VI program: https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf
- BsUFA II program: https://www.fda.gov/downloads/forindustry/userfees/biosimilaruserfeeactbsufa/ucm521121.pdf
- GDUFA II program: https://www.fda.gov/downloads/forindustry/userfees/genericdruguserfees/ucm525234.pdf
This meeting will provide FDA the opportunity to update interested public stakeholder on topics related to the financial management of PDUFA VI, BsUFA II, and GDUFA II. FDA will present the 5-year financial plans for each of these programs and discuss the vision for the resource capacity planning capability, as well as update participants on the progress towards implementing resource capacity planning and modernizing its time reporting approach. FDA will also address the impact of the fee structure changes on PDUFA VI and BsUFA II, as well as the contributions of the BsUFA spending trigger to the BsUFA program. Finally, the meeting will include a presentation from representatives of the MITRE Corporation or Grant Thornton on their evaluation of PDUFA, BsUFA, and GDUFA resource management during FY 2019 and FDA’s response to this evaluation.
Date and Location
June 7, 2019
9:00 - 12:00PM EST.
The meeting will be held at:
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center, Great Room (Rm. 1503)
Silver Spring, MD 20993-0002
Click here to learn more about visiting White Oak.
Please register to attend the event in-person or via webcast at Eventbrite . If you need special accommodations, please contact Graham Thompson at 301-796-5003 or Graham.Thompson@fda.hhs.gov by June 3, 2019 at 11:59 PM EST.