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. 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.
FDA, like other government agencies, is taking the necessary steps to ensure the agency is prepared to continue our vital public health mission in the event that our day-to-day operations are impacted by the COVID-19 public health emergency. Therefore, if it is determined that this public meeting should not be held at the FDA White Oak Campus, FDA intends to conduct a webcast for the public to participate in the public meeting. Any changes to the public meeting location and remote information, as appropriate, will be posted here in advance of the meeting.
- Webcast Link: https://collaboration.fda.gov/financialpublicmeeting
- Webcast Recording: https://collaboration.fda.gov/pts7aowe1z0y/
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.
Past Meeting Materials:
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.