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Session 5: Challenges and Opportunities of Differing Regulatory Paradigms for Drugs and Devices
Session Chair(s)
John K Towns, PhD
Director, Global CMC Regulatory Affairs
Eli Lilly and Company, United States
Drugs and devices are regulated by different FDA centers and are subject to different statutory law and regulations. Combination products precipitate these differences by requiring both a sponsor and the agency to work across these regulatory demarcations to advance development of a single regulated product having either a drug or a device primary mode of action. In this session, a panel of experts from the FDA, the medical device industry, and the biopharmaceutical industry will discuss their perspectives on the impact of bringing two products with different independent regulatory requirements together into one combination product - on product development and review and, importantly, on innovation.
Speaker(s)
Speaker
Steven B. Binion
Becton Dickinson, United States
Director, Policy, Technology, and Communication - Corporate Regulatory Affairs
Speaker
Nancy Stade, JD
Sidley Austin LLP, United States
Partner
Speaker
Patricia Love, MD, MBA
FDA, United States
Deputy Director, Office of Combination Products, OCPP, OC
Speaker
Robert Kelly
Bayer Healthcare Pharmaceuticals, United States
Senior Director, Regulatory CMC and Marketed Products
Speaker
Diane Johnson, MS
Johnson & Johnson, United States
Senior Director, North American Regulatory Affairs Policy and Digital Health
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