Meeting | Mixed
Event Title
Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment Public Meeting
September 24, 2025
- Date:
- September 24, 2025
- Time:
- 9:00 a.m. - 12:00 p.m. ET
On September 24, 2025, the Food and Drug Administration (FDA) held a hybrid public meeting titled "Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment," to meet performance commitments included in the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Amendments (BsUFA III). This assessment built upon the findings from three previous assessments conducted by independent contractors under previous PDUFA and BsUFA reauthorizations.
During the public meeting, FDA shared high-level findings from a third-party assessment of FDA’s hiring and retention of staff for the human drug review and biosimilar biological product review programs. An independent contractor presented their findings and recommendations, which are outlined in the Hiring and Retention Assessment report that was published on August 25, 2025.
For more background information on the meeting, please see the Federal Register Notice with assigned docket FDA-2025-N-2962. To provide a public comment, please visit the public docket. The public docket closes on October 24, 2025.
The meeting recording and transcript will be posted to this website as they become available.
Meeting Recording
Related Information
- Final FDA Hiring and Retention Assessment Report - December 2021
- Interim FDA Hiring and Retention Assessment Report - June 2020
- Initial Assessment of FDA Hiring and Retention Report - November 2017
- PDUFA VII Commitment Letter
- BsUFA III Commitment Letter