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31/01/2020 31/01/2020 America/Toronto Executive Think Tank on Rx Drug Advertising and Promotion Executive Think Tank on Rx Drug Advertising and Promotion
January 31, 2020
DoubleTree by Hilton Metropolitan, New York, NY
Please visit https://www.americanconference.com/Rx-Drug-Advertising-Think-Tank/ for more information and updates. DoubleTree by Hilton Metropolitan, New York, NY true DD/MM/YYYY 1440 use-title -
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31/01/2020 31/01/2020 America/Toronto Executive Think Tank on Rx Drug Advertising and Promotion Executive Think Tank on Rx Drug Advertising and Promotion
January 31, 2020
DoubleTree by Hilton Metropolitan, New York, NY
Please visit https://www.americanconference.com/Rx-Drug-Advertising-Think-Tank/ for more information and updates. DoubleTree by Hilton Metropolitan, New York, NY true DD/MM/YYYY 1440 use-title -
CFL Guidance Trial and Error Think Tank: Meeting the Three Factor Test
Nada Glavan
Senior Director, Commercial Regulatory Affairs, Neurology Business Unit
Eisai US
Richard Lem
Associate Director, Regulatory Affairs – Advertising and Promotion
Bayer Healthcare
This industry think tank will examine advertising and promotional practices within the context of the FDA’s CFL Guidance and three- factor test. Join us as we analyze recent interpretations of
the guidance and stories of success and failure:
- Understanding what it means to promote product information from within the label
- Exploring the concept of “out-of-label” claims
- Understanding how the requirements of the CFL guidance interact with the NDA process
- Does the claim need to be in the label or simply consistent with the label?
- Examining off- label communications in relation to the CFL Guidance and First Amendment challenges
- Understanding what it means to promote product information from within the label
- Discussing the impact of these challenges in the Amarian and Novartis cases