FDA partners Kathleen Sanzo and Michele Buenafe will present on "A Practical Look at Legal and Regulatory Issues in Promoting Diagnostics and Related Products" at the Advertising & Promotion Regulatory Affairs Conference presented by the Drug Information Association. Their panel will meet on Friday, March 1, from 9:15–10:15 am.
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.