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Meeting

Event Title
2022 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments
June 7, 2022


Date:
June 7, 2022
Time:
9:30 AM - 10:50 AM ET

Description

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, 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 and modernizing its time reporting approach.

This year’s public meeting will take place remotely on June 7, 2022 from 9:30 AM to 10:50 AM Eastern Time.

Federal Register: Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments

Docket No. FDA-2019-N-1875

2022 Meeting Materials

Date and Location

June 7, 2022

9:30 AM – 10:50 AM

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 ofbapbusinessmanagementservices@fda.hhs.gov by June 2, 2022, at 11:59 PM Eastern Time.

 


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