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Session 26: Review of Prescription Drug/Biologics Advertising and Promotional Labeling
Session Chair(s)
Michael Hamrell, PHD, RAC
President
MORIAH Consultants, United States
- Definitions
- Statutory Basis for Promotional Regulations
- Required Elements for Advertisements and Promotional Labeling
- Reminder Advertisements/Labeling
- Preapproval Promotional Activities
- Other Topics
- FDA Enforcement Actions
- Launch of Promotional Pieces
- Postmarketing Submission of Advertising
- Summary of Principles for Advertising and Promotion