U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. News & Events for Human Drugs
  4. Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments
  1. News & Events for Human Drugs

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

Description

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 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. 

This year’s public meeting will take place remotely on June 22, 2020 from 9 a.m to 11 a.m

Federal Register Notice

Docket No.FDA-2019-N-1875

2020 Meeting Materials

Date and Location

June 22, 2020
9:00 - 11:00 AM EST.
The meeting will be held virtually by webcast


Past Meeting Materials: 

Registration

Please register to attend the event via webcast. If you need special accommodations, please contact Monica Ellerbe at Monica.Ellerbe@fda.hhs.gov by June 3, 2020 at 11:59 PM EST.  

Back to Top