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Session 26: Review of Prescription Drug/Biologics Advertising and Promotional Labeling
Session Chair(s)
Elliott Berger, PhD, MS
President
ETB Regualtory Consulting, United States
- Definitions
- Statutory basis for promotional regulations
- Required elements for advertisements and promotional labeling
- Reminder advertisements/labeling
- Direct-to-Consumer (DTC) advertising
- Social media
- Disease awareness/help seeking
- Launch of promotional pieces
- Postmarketing submission of advertising
- Preapproval promotional and dissemination of off-label information
- FDA enforcement actions
- Summary of principles for advertising and promotion