Virtual
Event Title
BsUFA III Regulatory Science Pilot Program
October 16, 2023
- Date:
- October 16, 2023
- Time:
- 8:30 AM - 11:30 AM ET
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ABOUT THIS EVENT
The U.S. Food and Drug Administration (FDA) is hosting a two-part meeting on October 16 (virtual) and October 26 (in person), 2023.
The meeting agenda includes an overview of the regulatory science pilot program and discussion of the program’s current status as it relates to the BsUFA III commitments. The public component of the meeting on October 16 will also include presentations and panel discussions by FDA staff as well as internal and external awardees conducting research projects under the BsUFA III regulatory science program. In addition, FDA staff will present updates to the BsUFA III regulatory science program research priorities made in response to stakeholder feedback on the research roadmap.
The second day of the meeting will be held in person at the FDA White Oak Campus. During this section of the meeting, invitees will participate in round table discussions focused on progress, feedback, and recommendations to improve regulatory impact of the demonstration projects outlined under the program’s research priorities.
Due to capacity limits, participation in the in-person portion of the meeting will be first come-first served and requires attendance at the webinar component.
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 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
TOPICS
- 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 research priorities
- Stakeholder feedback and discussion on regulatory impact of the BsUFA III regulatory science pilot program, ongoing projects, and updates to the regulatory science roadmap
FDA RESOURCES
- Biosimilars | Science and Research
- BsUFA III Research Roadmap
- BsUFA Regulatory Research Pilot Program Research Awards
- BsUFA III: Fiscal Years 2023-2027