Philadelphia Chapter: FDA's New Promotional Standards & Their Impact on Off-Label Marketing

When:  Apr 4, 2019 from 5:30 PM to 8:00 PM

Thursday, 4 April 2019
5:30-8:00 pm EDT
Drexel UniversityKline Institute of Trial Advocacy
1200 Chestnut Street
Philadelphia, PA 19107
+1 215 895 1529

FDA finalized two major new guidances within the past year about the support required for promotional claims and how and when manufacturers can make such claims. These guidances have a dramatic impact for the ongoing debate regarding off-label marketing. This presentation will present a brief overview of the off-label marketing issue and the most recent developments in court cases regarding this vital topic. We will then dive into the most significant changes from the FDA's guidances and focus on the new standards for certain promotional claims as well as when the new standards apply.

At the conclusion of this presentation, attendees will learn:

  • the current state of off-label marketing prohibition
  • the most recent guidances from the Agency on off-label marketing and their impact on promotional efforts
  • the distinct standards applicable to different types of promotional claims

This event is coordinated by the RAPS Philadelphia chapter and is intended to encourage knowledge sharing and community development. A light meal will be available for all attendees and RAC holders may claim two RAC recertification credits.

Featured Speaker:
Dale Cooke, president, PhillyCooke Consulting

Registration Information:
Student: Free*
RAPS Members: $25
List: $40

*Contact RAPS Customer Service (+1 301 770 2920 ext. 200 or to get the student registration rate.



1200 Chestnut St
Philadelphia, PA 19107-4805