Labeling, Advertising and Promotion

Overview:
Although FDA does not have statutory authority to regulate advertising and promotional activities per se, FDA does regulate the labeling of medical products. And since the courts have held that most, if not all, advertising and promotional activities are labeling, FDA is very interested in what you say about your products in the marketplace, to customers, and on the trade show floor.

Instructional methods include: Lecture format, with questions/answers/discussion throughout.

How You Will Benefit:
By the end of the course, participants will have gained:

How labeling, advertising, and promotion are related, and how they’re regulated
How to ensure their labeling, advertising, and promotional materials are compliant
When its safe to distribute off-label materials

Course Topics:

What is Labeling?
What is Advertising and Promotion?
What are Claims?
Product claims
Promotional claims
Intended Use
Indications for Use
How does FDA regulate advertising and promotion? What role do FTC and FCC play?
What is off-label use? Is it ever safe to distribute off-label material?
How do we deal with this? (What CAN I say about my product?)
How can we ensure that we are compliant (labeling review process)?

Who Should Attend:
Anyone who is involved in complaint handling and/or adverse event reporting: R&D, Mfg, RA/QA, sales/marketing personnel.