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The Food and Drug Administration (FDA) is holding a hybrid public meeting titled "Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment." The meeting includes an opportunity for public comment. This public meeting is being held to meet performance commitments included in the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Amendments (BsUFA III). During the public meeting, FDA will share high-level findings from a third-party assessment of FDA’s hiring and retention of staff for the human drug review program conducted by an independent contractor, Eastern Research Group, Inc. (ERG). The current assessment builds upon the findings from three previous assessments conducted by independent contractors under PDUFA VI and BsUFA II. ERG will present their findings and recommendations, which are outlined in the Hiring and Retention Assessment report that was published on August 25, 2025 and FDA will provide a response. This meeting will take place in person and virtually. During online registration you may indicate if you wish to make comments during the public comment session. All requests to make a public comment during the meeting must be received via registration by September 15, 11:59 p.m. Eastern Time.

Registration

To register for the public meeting, please visit the following website to register: Eventbrite Meeting Registration 

Public Docket

In addition to providing input at the public meeting, stakeholders are invited to provide their perspectives through the public docket.

Related Information

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