Thursday, 4 April 20195:30-8:00 pm EDTDrexel University, Kline Institute of Trial Advocacy1200 Chestnut StreetPhiladelphia, 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:
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: $25List: $40
*Contact RAPS Customer Service (+1 301 770 2920 ext. 200 or support@raps.org) to get the student registration rate.
Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 400Rockville, Maryland 20852
raps@raps.org+1 301 770 2920
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