Creative labeling, as innocent as it may seem, can earn you an FDA warning letter. The FDA does not provide guidance on how to avoid regulatory action even if your message is true, if it is attention getting or simply a flattering description of your product. The FDA’s objection to labeling that uses music and the word “love” casts a new cloud of uncertainty for what you can and cannot say. The agency’s reasoning creates more questions and fears about what misbrands a product. It looks like marketing’s creativity just took a hit. Firms are in the lurch about what sales and marketing can say about the product. You must now consider some basic pitfalls and add in some more subtle considerations for how and what you communicate.
The FDA suspects its labeling requirements are self-defeating but still holds on to the decades old approach. Will that change? Can it change? Will you take FDA to federal court? That’s expensive. Will you tone down your marketing creativity so the product is not deemed illegal? Keep in mind that recalling misbranded products is expensive.
Join this session, where expert speaker Casper E. Uldriks will discuss the new types of labeling hot spots that can prompt a warning letter. Casper will focus on the new “no nos” so you don’t end up with a warning letter.
With this session, you will learn how what you say and how you say it makes a big difference to the FDA. You will see how the FDA is aggressively expanding its interpretation of labeling and advertising. You will also learn how the regulatory affairs and marketing departments in your organization can reconfigure their labeling and advertising boundaries and regulatory risks.
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specializes in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He...
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