Navigating Human Factors for Combination Products, Including Generic: URRA, Threshold Analysis and Post Market

Friday, November 14, 2025

8:10 AM - 9:25 AM East Coast USA Time

Moderator(s)

Rumi Young

Director, Regulatory Policy
Novo Nordisk

Speaker(s)

Matt Marber

Senior Usability Engineer
Novo Nordisk
Tina Rees

Director, Human Factors
Regeneron
Jiaying Shen

Executive Director, Medical Device and Combination Product Development, Regulatory and Quality
Merck
Lolita Sterrett

Associate Director for Human Factors, Division of Medication Error Prevention and Analysis, Center for Drug Evaluation and Research (CDER)
FDA (Virtual)

Leveraging URRA Guidance and Threshold Analyses for Combination Products development, including Generic. This session covers FDA guidance on use-related risk analyses (URRA) released in 2024 and the role of threshold analyses (TA) in simplifying combination product development through established human factors knowledge. FDA speakers will share their perspective on whether the URRA guidance is effective in terms of enhancing product safety and user experience, and they'll also discuss the criteria for successful TA. Industry speakers will share insights on the tools to implement URRA guidance, how to conduct meaningful TA analyses, and how companies can meet FDA expectations while ensuring regulatory compliance.

Human Factors in Development vs. Post-Market Considerations: The human factors approach differs significantly between new product development and post-market surveillance. Explore the distinct methodologies and challenges faced in both phases. The industry speaker will share how insights gained during post-market monitoring can inform future product iterations, enhance user support, and drive continuous improvement in product design and usability.