New FDA Guidance for Direct-to-Consumer Promotional Labeling and Advertisements

Event Information
Product Format
Live Webinar
Conference Date
Add to my calendar   Tue, Jan 08, 2019
Aired Time
1 pm ET | 12 pm CT | 11 am MT | 10 am PT
60 minutes
Product Description

Learn How to Promote Your Products in Line With the FDA’s New Draft Guidance

The FDA released a new draft guidance document in October 2018 on the topic of efficacy and risk information in Direct-To-Consumer (DTC) promotional labeling and advertisements. The new guidance provides industry professionals with the knowledge necessary to ensure that prescription drug promotional materials are truthful and not misleading, especially in regard to a product’s benefits and risks. If you’re not fully on top of the new guidance, even a small mistake can prove to be costly later.

Get detailed insights on the new FDA guidance document with industry expert Kelly Thomas, who will educate you on the agency’s recommendations and expectations in regard to DTC promotional labeling. Thomas will bring you up to speed with the regulatory requirements governing DTC promotional labeling, and also show you how to apply them. She will explain the new regulatory expectations regarding visual aids, and how to present quantitative risk data, and apprise you of the consequences of non-compliance.

After attending this session, you will clearly understand the DTC promotional labeling regulatory requirements. Plus, you will know how to apply those requirements clearly, concisely, and informatively to your promotional materials without falling foul of the FDA.

Session Highlights

Sign up for this webinar to understand and know:

  • The regulatory requirements governing DTC promotional labeling
  • How to apply those regulatory requirements
  • How to present quantitative risk data compliantly
  • The regulatory expectations regarding visual aids
  • The consequences of non-compliance to DTC promotional labeling regulations

Session Agenda

Topic 1:   Review History of DTC Promotional Labeling

  • A Decade of Evolving Regulation

Topic 2:  Review DTC Promotional Labeling Regulatory Requirements

  • Food Drug & Cosmetics Act (FDCA)
  • 21 CFR 202

Topic 3:  Review Concepts Detailed in the October 2018 FDA Guidance

  • How to present quantitative risk data so that it is understood by the consumer
  • Proper use of Visual Aids to illustrate quantitative efficacy or risk information

Topic 4:  Understand the consequences of Non-Compliance

  • Review potential outcomes for Non-Compliance
  • Review Recent Regulatory Actions Regarding DTC Promotional Labeling Non-Compliance
    • FDA Enforcement Actions: Warning Letters, Consent Decrees, Injunctions, Seizuress

Who Should Attend

  • Quality assurance staff
  • Regulatory affairs staff
  • Pharma, biotech, and medical device professionals
  • Anyone involved with FDA

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Kelly  Thomas

Kelly Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. 

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering...   More Info
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