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The Westin Boston Waterfront

Aug 13, 2018 7:45 AM - Aug 16, 2018 5:00 PM

425 Summer Street, Boston, MA 02210

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)

Michael Hamrell, PhD, RAC

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
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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