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Sheraton Philadelphia University City

Oct 22, 2018 1:45 PM - Oct 25, 2018 11:00 PM

3549 Chestnut Street, Philadelphia, PA 19104

Regulatory Affairs: The IND, NDA, and Post-Marketing

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Session 25: Review of Prescription Drug/Biologics Advertising and Promotional Labeling

Session Chair(s)

Elliott Berger, PhD, MS

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
Post-Marketing Submission of Advertising
Preapproval Promotion and Dissemination of Off-Label Information
FDA Enforcement Actions

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