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Session 11: One Application or Two? Different Approach to Different Pathways for Approval Process
Session Chair(s)
Rachel Turow, JD, MPH
Managing Counsel, FDA Regulatory
Walmart, Inc., United States
This session will discuss the various FDA guidances and federal register notices that try to tackle the question of when it might be appropriate to evaluate a combination product under two different applications. This issue is especially important for cross-labeled combination products, devices referencing drugs, and digital health combination products.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe the legal and regulatory framework around the type and number of applications necessary for different approaches to combination products
- Discuss a case study of a combination product submitted under one or two applications and the different regulatory implications
Speaker(s)
Regulator Perspective
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC
Industry Perspective: Pre-Market Pathways for Combination Products
Matthew Raymond, PhD
Astellas, United States
Director, Science and Regulatory Policy
Regulatory History of Cross-Labeled Combination Products and Devices Referencing Drugs
Suzette Roan, JD, MS
Sanofi, United States
Senior Director, GRA Device Combination Products
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