January 22, 2025
The U.S. Food and Drug Administration (FDA) Biosimilar User Fee Act (BsUFA) III Regulatory Science Pilot program is hosting its second virtual event.
The agenda includes a recap of the activities of this regulatory science pilot program from the last engagement that occurred on October 16, 2023. Additionally, the webinar will include a status update on the program’s current research portfolio as it relates to the BsUFA III commitments as well as presentations and panel discussions by FDA staff. Lastly, FDA staff will present the next steps planned for the BsUFA III regulatory science program.
Intended Audience
- Regulatory science and regulatory affairs professionals working on scientific, public health, or policy issues related to biosimilar biological products or who submit Biologics License Applications (BLAs) under the abbreviated 351(k) licensure pathway
- Biosimilar product developers
- Researchers working on methodologies to advance biosimilar development
- Foreign regulators working in biosimilar and interchangeable product regulation
- Pharmacists and clinicians
- Patients or patient advocacy groups
- Biological product manufacturers
- Representatives from consortia or other organizations interested in improving access to biological products
Topic Covered
- BsUFA III regulatory science pilot program overview and status
- BsUFA III regulatory science pilot program project vignettes
- Updates to the BsUFA III regulatory science pilot program next steps
- Stakeholder feedback and discussion on the BsUFA III regulatory science pilot program next steps and ongoing projects
Resources
visit the FDA.gov webpage
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