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Session 26: Review of Prescription Drug/Biologics Advertising and Promotional Labeling
Session Chair(s)
Drusilla Scott, PhD, RAC
Vice President, Regulatory Affairs
Sobi, Inc., United States
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, 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
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