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Session 6: The Future of Generic Combination Products
Session Chair(s)
Rachel Turow, JD, MPH
Managing Counsel, FDA Regulatory
Walmart, Inc., United States
This session will explore the challenges and successes of bringing generic drug-device combination products to market. We also will discuss FDA’s current policy on “sameness” for generic drug-device combination products, both from a human factors perspective and a labeling perspective.
Learning Objective : At the conclusion of this session, the participant should be able to:- Discuss areas where drug-device combination products can differ from innovator products but also be considered the same
- Identify challenges to comparative human factors testing for generic combination products
- Analyze different pre-market approaches to interacting with FDA when developing a generic drug-device combination product
Speaker(s)
Regulatory Considerations for Generic Combination Products
Anil Sachdeva, MPharm, RAC
Teva Pharmaceutical Industries Ltd., United States
Senior Director, Regulatory Affairs, Gx Steriles
Panelist
Lisa Bercu, JD
FDA, United States
Regulatory Counsel, Office of Generic Drug Policy
Panelist
Lisa Parks, RPh
CHPA, United States
Senior Vice President, Regulatory and Scientific Affairs