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Product Communications in the Preapproval Phase
Session Chair(s)
Mark Gaydos
Global Head, Advertising & Promotion, Global Regulatory Affairs
Sanofi, United States
This session will focus on the types of information a company might consider communicating about its research efforts, pipeline products and corresponding development programs. Select topics include: What, how, and to whom can companies communicate about research efforts and pipeline products while avoiding allegations of preapproval or off-label promotion? What and when can a company proactively communicate about planned and ongoing clinical trials? What are the parameters a company should observe when developing a preapproval disease awareness campaign? What are the pros and cons of a "coming soon" campaign?
Learning Objective : Discuss the types of information companies might consider communicating in the pre-approval phase; Identify the communications pros and cons in the pre-approval phase.
Speaker(s)
Enforcement Action Summary
Mark Gaydos
Sanofi, United States
Global Head, Advertising & Promotion, Global Regulatory Affairs
Emerging Communication Channels in Preapproval Communication: Does the Medium Matter?
Dennis Lawrence Nosco, PhD, RAC
Mallinckrodt, United States
Senior Director, Global Labeling, Regulatory Affairs
Impact of Caronia on Preapproval Communications
Alan R Bennett, JD
Ropes & Gray, United States
Senior Counsel
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