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‘Consistent Communications’ and the FDA’s Expansion of Promotional Boundaries
Presented By: Norma Skolnik
Live Webinar
Date: Tuesday, December 05, 2017| Duration: 60 minutes
Time: 1 pm ET | 12 pm CT | 11 am MT | 10 am PT
REGISTER NOW
Understand the Scope of the FDA’s New Consistent Communications Guidance
The FDA’s draft guidance on medical product communications and FDA-required labeling is complex. The guidance allows medical product firms interested in communicating information about the approved and cleared uses of their products that are not contained in their products’ FDA-required labeling to do so provided the information is consistent with FDA-required labeling. However, communication consistent with FDA-required labeling may still be subject to enforcement action, and it is essential that you understand the scope and limitations of the guidance as it applies to your company’s product marketing and promotional activities.

In this session, expert speaker Norma Skolnik will cover the FDA’s recent policy expansion of the bounds for medical products advertising and promotion. Norma will help you understand the scope of FDA’s new Consistent Communications Guidance and its implications for your company’s product marketing, product promotion and advertising initiatives. In this session, you will also get the required tools and references to all applicable FDA regulations and guidance documents (including website references). Read more
Session Highlights
  • Background on the FDA’s past approach to medical products advertising and promotion
  • What led up to the FDA’s new approach
  • Overview of the FDA’s Draft Guidance on Consistent Communications
  • Factors that must be met for compliance with the consistent communications concept
  • Necessary advertising claims substantiation under the new guidance
  • Relevance and application of the guidance for your company
  • And more
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About Our Speaker
Norma SkolnikNorma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Read more
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