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Bethesda North Marriott Hotel and Conference Center

Apr 08, 2019 1:45 PM - Apr 11, 2019 11:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

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

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Session 24: Requirements for Prescription Drug 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
Pre-Approval Promotion and Dissemination of Off-Label Information
FDA Enforcement Actions

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