Building a World-Class Advertising and Promotion Review Program


8:00 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 9:45 a.m.

Pre-approval Communications

  • How to meet your SEC requirements for disclosing information while not running afoul of FDA pre-approval promotion prohibitions

9:45 a.m. – 10:30 a.m.

From Day of Approval through Commercial Launch

  • Understanding the timeline and key dates for communications
  • Minimizing the pain, while maximizing the impact of initial promotional communications

10:30 a.m. – 10:45 a.m.


10:45 a.m. – 12:15 p.m.

Essential Advertising & Promotion Regulations

  • A review of all of the requirements for product promotion of drugs and medical devices, including product name usage, fair balance, and directions for use

12:15 p.m. – 1:15 p.m.


1:15 p.m. – 2:00 p.m.

Disease Awareness Communications

  • A review of FDA’s withdrawn guidance on help-seeking communications
  • Keys for using disease awareness communications prior to approval
  • Essential information for continuing efforts after approval compliantly

2:00 p.m. – 2:45 p.m.

Format-Specific Promotional Requirements

  • Brief Summary Requirements for Print Promotion
  • DTC Television Promotion vs. YouTube Promotional Videos
  • Developing a major statement

2:45 p.m. – 3:00 p.m.


3:00 p.m. – 4:30 p.m.

Substantial Evidence & Other Standards

  • A review of the substantial evidence standard, what fails to meet that standard, and when other standards apply

4:30 p.m. – 5:00 p.m.

Off-Label Information

  • Avoiding Off-Label Promotion
  • Scientific Exchange Exemption
  • Responding to Unsolicited Requests
  • Distributing Off-label Reprints
  • Latest court cases and other developments in off-label information

5:00 p.m.

Session Wrap-up, End of Day One



Day 1 | Day 2

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