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Session 10: Track B: A Practical Look at Legal and Regulatory Issues in Promoting Diagnostics and Related Products
Session Chair(s)
Kathleen M Sanzo
Partner
JD, Partner, Morgan, Lewis & Bockius LLP, United States
In the advertising and promotion regulatory arena, diagnostic products – which can include formally FDA-regulated IVDs, research use only (RUO), and laboratory developed tests (LDTs) -- present challenges for industry that can differ markedly from other products. This session will explore the differences between what can be claims for an IVD vs. an RUO product vs. an LDT. We will delve into specific claim language and practical examples to help you stay on top of advertising and promotion challenges in this world, which has undergone great changes in recent years.
Learning Objective : At the conclusion of this session, participants should be able to:- Identify how lawful advertising claims differ and why among IVDs (i.e., those under FDA control) vs. research use only (RUO) products vs. LDTs, or Laboratory Developed Tests
- Discuss best practices in advertising of IVDs, RUOs, and LDTs
- Describe the traps for the unwary in promotional claims for these sometimes similar products
Speaker(s)
Speaker
Michele L. Buenafe, JD
Morgan, Lewis & Bockius LLP, United States
Partner
Kathleen M Sanzo
JD, Partner, Morgan, Lewis & Bockius LLP, United States
Partner