Skip to main content
2024 National Biotechnology Conference Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Back

Novel Strategies to Advance Biotherapeutic Development

Hot Topic: Navigating the New FDA Immunogenicity Labelling Guidance

Thursday, May 16, 2024
2:00 PM – 3:00 PM PT
Location: Yosemite A
Novel Strategies Hot Topic
This session will include a brief overview of the new FDA labeling guidance and implications for the industry. This will be followed by brief presentations of case studies prepared by scientists that have leveraged the new labels for legacy and new products and what their experience has been. There will also be a brief presentation from an FDA representative describing impact and lessons learned from one year of implementation. This will be followed by a panel discussion that will allow questions from the audience to all of the speakers.

Learning Objectives:

  • Understand the requirements of the new FDA immunogenicity labeling guidance.
  • Implement best practices to implement the new labeling requirements.
  • Develop a strategy for their company to both develop labels for new therapeutics and revise current labels to comply with the new standard.