An Introduction to Applicable FDA Offices, Essential Principles, & Key Definitions for Medical Product Advertising and Promotion
Discuss the relevant FDA offices that regulate advertising and promotional labeling of medical products, including drugs and medical devices for both human and veterinary use. Explore essential definitions and principles of medical product advertising and promotion.
Why it Matters
- FDA Offices
- FDA Enforcement
- Key Definitions and Essential Principles of Advertising and Promotional Labeling
- Types of Claims
- Disease Awareness (Unbranded)
- Traditional and Other Forums
- Preapproval Communications
- Submissions
Stephanie Jameison, Sr. Director, Global Regulatory Affairs, Promotion Compliance, Otsuka America Pharmaceutical, Inc.
This session was recorded as part of FDLI’s Virtual Introduction to Advertising and Promotion for Medical Products Course in October 2022.
STEPHANIE HAYES JAMEISON is Senior Director, Promotion Compliance, at Otsuka Pharmaceutical Development & Commercialization, Inc., where she provides regulatory oversight and ensures compliance for the company’s marketed products. She also interacts with the FDA as a corporate liaison. Jameison began her career as a Biomedical Engineer at a biotechnology company, and subsequently leveraged her scientific background to transition into regulatory affairs. With over 20 years of expertise in advertising and promotional regulations, she has made significant contributions towards bringing products to market that address serious and unmet needs.Get Access
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