Public Meeting on PDUFA VII/ BsUFA III Hiring and Retention Assessment

The Food and Drug Administration (FDA) is holding a hybrid public meeting to meet performance commitments included in the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Amendments (BsUFA III). The public meeting entitled "Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment," will discuss a hiring and retention assessment, which was performed by an independent contractor.

This public meeting will provide FDA the opportunity to update interested public stakeholders on topics related to hiring and retention in the FDA human drug review program. The independent contractor will present their findings and recommendations, which are outlined in the Hiring and Retention Assessment Report. The FDA will provide its perspective on the independent contractor’s findings and recommendations.

This meeting will also provide an opportunity for public comment. All requests to make a public comment during the meeting must be received via registration by September 15, 11:59 p.m. Eastern Time. Onsite registration for public comments on the day of the public meeting will not be provided.

As it becomes available, additional information (e.g., the federal register notice, the public meeting agenda) will be provided here: https://www.fda.gov/drugs/news-events-human-drugs/prescription-drug-user-fee-act-and-biosimilar-user-fee-amendments-hiring-and-retention-assessment

In- Person Location: FDA 10903 New Hampshire Avenue Great Room (Enter at Building 1 to clear security) Silver Spring, MD 20903. For information on parking, please view the Visitor Parking and Campus Map.

Webinar Location: Microsoft Teams

Host or Publisher FDA