Bradley Merrill Thompson, Member of the Firm, will present “Intended Use & Off-Label Promotion” at the US Regulation of Advertising, Promotion, and Labeling for Medical Devices Virtual Program, hosted by the Regulatory Affairs Professionals Society (RAPS).
- Understanding the law and past FDA enforcement of off-label use promotion
- Mechanisms of discussing off-label uses
- Off-label use and clinical trial strategy
- The context of off-label use discussions
- Social media promotion and other evidence of intended use
- Legal challenges to FDA enforcement
For more information, please contact Mr. Thompson.