The FDA’s Expansive Control Over Promotion and Advertising

Image credit: www.flickr.com by Ryan Van Etten
Duration 60 Mins
Webinar ID IQW22H0819
Level Basic & Intermediate & Advanced

  • What is considered “off-label”
  • Vulnerability to social media
  • Direct to Consumer promotion pitfalls
  • Fair and balanced information

Overview of the webinar

FDA’s sweeping definition of labeling includes what is said or represented, even by images, on a social media platform.  If the information can reach a consumer, FDA cares, even if you did not publish the information.  Firms need to watch for promotional trespassers making off-label claims. Websites, chat rooms, op-ed articles, or even your own postings on social media can cause your product to be misbranded, i.e., illegal.  One big issue is how you patrol and control what someone else is saying about your product in a public forum.  Once the off-label information is out there, what is the scope of your responsibility?

Who should attend?

  • Regulatory Affairs Directors
  • Marketing Directors
  • Sales Managers
  • Website Managers
  • Importers
  • Clinical establishments/institutions
  • Clinical sponsors
  • Quality Assurance Managers

Why should you attend?

  • Understand how parameters of labeling
  • Learn how third parties place you in jeopardy
  • Understand FDA’s concern about “fair and balanced” information
  • Ways to define your social media responsibilities
  • Apply FDA Guidance Documents on DTC / social media labeling

Faculty - Mr.Casper Uldriks

Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA.  He specialized 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. His comments are candid, straightforward and of practical value.  He understands how FDA thinks, how it operates and where it is headed.  Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.  Professional credentials: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.

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