Zdrowie i gospodarka · 12/12/2025
FDA Requests Stakeholder Notification for Biosimilar User Fee Act Reauthorization Consultation Meetings
The FDA is requesting public stakeholders to notify their intention to participate in consultation meetings on reauthorizing the Biosimilar User Fee Act (BsUFA), which expires in September 2027. The agency aims to establish consistent stakeholder representation to ensure continuity and progress in monthly discussions with patient and consumer advocacy groups.