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Sheraton Philadelphia University City

2019 年 10 月 14 日 7:45 上午 - 2019 年 10 月 17 日 5:00 下午

3549 Chestnut Street, Philadelphia, PA 19104

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

Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.

返回 Agenda

Session 24: Requirements for Prescription Drug Advertising and Promotional Labeling

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, 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