In this “lunch and learn” Opus Insights webinar, our team of expert consultants in Regulatory Advertising and Promotion break down the FDA’s “Clear, Concise, and Neutral” rule (CCN Final Rule) through a series of case studies and evidence-based research.
Presenters:
Kit Aikin brings 25+ years of FDA experience supporting and leading the Social Science Research Team at OPDP . She has led qualitative and quantitative social and behavioral science research evaluating DTC, DTP, and HCP promotional materials and served as a subject matter expert for regulatory review.
Tim Candy brings ~20 years of industry experience with deep expertise in regulatory advertising and promotion. He has extensive hands-on experience in DTC strategy and execution, helping organizations navigate complex promotional requirements while maintaining effectiveness and compliance.
Learning Objectives:
Summarize the most recent violations related to FDA's Clear, Conspicuous, and Neutral (CCN) Rule for presenting the major statement in broadcast TV ads.
Understand what dual modality is (and is not) in the context of the major statement and why this standard is part of the CCN Rule.
Recognize how existing social science research can help identify common violation triggers for visuals that interfere with comprehension of the major statement.
Benefits of Attendance:
Learn directly from FDA and industry expertise: Gain both regulatory authority perspective and real-world application from two highly experienced leaders.
Understand what triggers violations: Learn how visuals can unintentionally interfere with comprehension of the major statement—and how to avoid common pitfalls.
Apply social science to compliance: Discover how existing research can help you proactively identify risk areas and strengthen your promotional review process.
Stay ahead of evolving expectations: With increased scrutiny on DTC and HCP materials, this session will help you align with current thinking around CCN guidance.
Practical, actionable takeaways: Walk away with strategies you can immediately apply to reduce regulatory risk and improve communication effectiveness.