CUHFS: Exploring More Efficient Human Factors Evaluation Methods
Monday, October 27, 2025
2:30 p.m. - 3:30 p.m.
This session will explore human factors evaluation framework for both generic and interchangeable combination products with the following key objectives:
- Understand the current framework and challenges associated with Comparative Use Human Factors studies (CUHFS)
- Discuss proposals for improvements and alternatives to CUHFS
- Continue the Industry & FDA conversation regarding implications and opportunities for future product submissions and guidances
Participants:
Cristina Ausin, PhD
Scientific Reviewer, OTBB, OND, CDER, FDA
Andrew Clerman, M.D., PhD
Acting Lead Physician, DTPI, ORS, OGD, CDER, FDA
CDR Andrew Fine, PharmD, BCPS
Senior Advisor, Division of Clinical Review, Office of Safety and Clinical Evaluation, OGD, CDER, FDA
Johannes Keuschnigg, PhD
Regulatory Devices Portfolio Head, Sandoz
Carrie O’Donel, MS
Associate Director, MS&T, External Manufacturing, Teva Pharmaceuticals
Moderator: Chris Lamanna, PhD
Head Regulatory Devices, Sandoz
