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

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Duration : 60 min





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Background

The FDA released a new draft guidance document in October 2018 on the topic of efficacy and risk information in direct-to-consumer promotional labeling and advertisements.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


Session Highlights

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 Professionals

.  Regulatory Affairs Professionals

.  Professionals from the Pharmaceuticals, Biotech, Medical Device

.  Anyone involved with FDA

 

 










































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