DIA 2013 49th Annual Meeting
Click here to go to the previous page
Product Communications in the Preapproval Phase
Track : Track 05: Regulation of Product Advertising and Marketing in an Ever-changing World
Program Code: 270
Date: Tuesday, June 25, 2013
Time: 4:00 PM to 5:30 PM  EST
Location: 102AB
CHAIR :
 Mark Gaydos, (SCHNON), Vice President, US Regulatory Affairs Marketed Products, Sanofi US, United States
SPEAKER (S):
 Mark Gaydos, (SPKNON), Vice President, US Regulatory Affairs Marketed Products, Sanofi US, United States
 Dennis Lawrence Nosco, PhD,RAC (SPKNON), Senior Director, Global Labeling, Regulatory Affairs, Mallinckrodt, United States
Alan R Bennett, JD (SPKNON), Managing Partner, DC Office, Ropes & Gray, United States
Description
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?