Combination Products Conference

Where regulators and industry share insights on leveraging regulatory and technological change to advance combination products.

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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