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Session 25: Review of Prescription Drug/Biologics Advertising and Promotional Labeling
Session Chair(s)
Elliott Berger, PHD, MS
President
ETB Regulatory 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
- Post-Marketing Submission of Advertising
- Preapproval Promotion and Dissemination of Off-Label Information
- FDA Enforcement Actions