The FDA released a new draft guidance document in October 2018 on the topic of efficacy and risk information in Direct-To-Consumer (DTC) promotional labeling and advertisements.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.
Sign up for this webinar to understand and know:
Topic 1: Review History of DTC Promotional Labeling
Topic 2: Review DTC Promotional Labeling Regulatory Requirements
Topic 3: Review Concepts Detailed in the October 2018 FDA Guidance
Topic 4: Understand the consequences of Non-Compliance
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.
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.