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Sheraton Boston Hotel

Aug 14, 2017 7:30 AM - Aug 17, 2017 5:00 PM

39 Dalton Street, , Boston, MA 02119 , USA

Regulatory Affairs: The IND, NDA, and Postmarketing

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Session 26: 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
Postmarketing submission of advertising
Preapproval promotional and dissemination of off-label information
FDA enforcement actions
Summary of principles for advertising and promotion

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