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Session 9: Devices Referencing Drugs: Post-Market Considerations
Session Chair(s)
Nancy Stade, JD
Partner
Sidley Austin LLP, United States
Response to FDA’s proposal to create a marketing pathway for devcies that reference drugs in their labeling (Devices Referencing Drugs or DRDs) has been largely split. While the device industry has focused on the need for such a pathway because current incentives may disfavor collaboration by drug manufacturers, pharma and bio manufacturers generally have focused on regulatory and product safety impediments to the pathway. This panel will examine challenges in post-market oversight of DRDs, identify how FDA has addressed such challenges in the past, and explore whether and under what circumstances FDA can exert sufficent oversight over DRDs to warrant the creation of a pathway.
Learning Objective : Upon completion of this session, participants should be able to:- Define a DRD
- Identify one current legal or policy obstacle to approving/clearing DRDs
- Identify one legal or policy argument before or against creating a DRD pathway
Speaker(s)
Panelists
Kirk Seward, PhD
Mercator Medical, United States
Co-founder, President, Chief Science & Technology Officer
Panelists
Christy L. Foreman
Biologics Consulting, United States
Senior Consultant
Panelists
Diane Johnson, MS
Johnson & Johnson, United States
Senior Director, North American Regulatory Affairs Policy and Digital Health
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