New FDA Guidance for Direct-to-Consumer Promotional Labeling and Advertisements
11:30 AM ET | 08:30 AM PT | 10:00 AM CT Duration 60 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar
"Ms. Kelly Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations."
Detailed overview of the new FDA guidance document in order to educate participates on the agency’s
The FDA released a new draft guidance document in October 2018 on the topic of efficacy and risk information in direct-to-consumer promotional labeling and advertisements. The guidance document provides industry with advice on how to present effectiveness and risk information in consumer ads in such a way that it is easily understood by consumers. It is essential that a product’s benefits and risk are clear, concise and informative. Therefore, the goal of the new guidance is to provide 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.
Why should you attend
This course will provide a detailed overview of the new FDA guidance document in order to educate participates on the agency’s recommendations and expectations in regard to Direct-to Consumer promotional labeling.
Course Participates will:
Understand the regulatory requirements governing DTC promotional labeling
Understand how to apply those requirements
Explain the new regulatory expectations regarding how to present quantitative risk data
Understand the regulatory expectations regarding visual aids
Understand the consequences of non-compliance to DTC promotional labeling regulations
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
o FDA Enforcement Actions: Warning Letters, Consent Decrees, Injunctions, Seizers
Who will Benefit
• Quality Assurance
• Regulatory Affairs
Industries who can attend
This 60 minute online course is intended for professionals in the Pharmaceutical and Biopharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.