Audio Conference

Indications: The Next Battleground in FDA Advertising Enforcement Robert J. Klepinski Fredrikson & Byron Purchase recording US$199

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Recent Supreme Court decisions have provided new protection to commercial speech, challenging the manner in which FDA regulated industry. In response, FDA has shifted its enforcement activities, being careful not to mention advertising. Instead FDA has begun focusing on indications. The Food, Drug, and Cosmetic Act does not give FDA broad control over advertising. However, it gives FDA explicit control over the approval/clearance process and the resulting indications. FDA is tightening up on statements in ads by closely interpreting indications. This places new importance on the manner in which indications are written. In this audio conference, we will discuss how best to work within this new reality.

This audio conference will address:

• The FDA shift in focus to indications
• What this means for medical device companies
• The need to establish bounds for your indications
• How to keep your claims within those bounds
• Where indications are headed in the future
  

About the speaker:

Robert Klepinski is an Officer with Fredrikson & Byron and practices in the Food and Drug Administration, Health Care Fraud & Compliance and Intellectual Property service areas. He is also recognized as one of the leading FDA compliance attorneys. He counsels pharmaceutical, medical device, biotech, food and nutritional supplement companies on FDA policy. Previously, he served as a regulatory attorney for Medtronic. While there, he set the legal strategy for FDA compliance, including advertising and promotion, quality systems, regulatory and clinical.

Robert frequently speaks at local and national trade associations on FDA policy. He has been an adjunct professor at the University of Minnesota Law School and a guest lecturer at other law schools, including Northwestern University, Hamline University and William Mitchell College of Law. He is an adjunct professor at St. Thomas University Graduate School of Engineering and its MBA program.

Who should attend?

• Regulatory Affairs
• Marketing
• Legal Counsel
• Management

Purchase Options

• Purchase a recording of this event US$199