The Caronia Court Decision and Off-Label Promotion 2013

Key Topics

• The statutory and regulatory concepts of the product label
• FDA’s regulation of product labels and labeling
• FDA enforcement action against companies for off-label promotion prior to the Caronia case decision
• Product labeling as applied to both pharmaceuticals and medical devices
• The Caronia case and explanation of the Court’s decision
• The Department of Justice’s recent series of court cases and penalties for off-label promotion
• The potential impact that the decision in the Caronia Case might have on pharmaceutical and medical device companies moving forward and in the future

Who should Attend

• Pharmaceutical and Drug Companies, Medical Device and Biotech Companies, Start-ups, Foreign Drug Companies and Device Manufacturers, Importers
• Regulatory Affairs Professionals, Managers, Consultants, Scientists, Research Analysts, State Officials, Insurers; Investment Analysts; Venture Capitalists
• Financial analysts and investors watching the pharmaceutical, life sciences and biotech industries
• Marketing and Advertising Professionals and Experts; Consultants