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Sheraton Philadelphia University City

Oct 23, 2017 7:30 AM - Oct 26, 2017 5:00 PM

3549 Chestnut Street, Philadelphia, PA 19104

Regulatory Affairs: The IND, NDA, and Postmarketing

Back to Agenda

Session 26: 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
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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