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Session 2: Complex Generic Combination Products – Regulatory Policy Considerations
Session Chair(s)
Rachel Turow, JD, MPH
Managing Counsel, FDA Regulatory
Walmart, Inc., United States
Building on the progress of DIA’s Complex Drug-Device Generic Combination Products meeting, this session will address regulatory policy issues raised by the review and approval of complex generic combination products. Specifically, we will look at how FDA defines “sameness“ with respect to device functionality; human factors requirements; and other policy considerations.
Learning Objective : Upon completion of this session, participants should be able to:- Understand significant regulatory issues impacting complex generic combination products
- Describe the standard of “sameness” for complex generics
- Give examples of challenges faced in the development of complex generic combination products
Speaker(s)
Complex Generic Combination Products – Regulatory Policy Considerations
Lesley DeRenzo
FDA, United States
Regulatory Counsel, Office of Generic Drugs, CDER
Complex Generic Combination Products – Regulatory Policy Considerations
Cory Wohlbach
Teva Pharmaceuticals, United States
Global Vice President, Biosimilar Regulatory Affairs
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