Some Hot FDA Regulatory Trends in Product Promotion

Event Details


May 30-31, 2012

Add To Calendar



“Some HOT FDA Regulatory Trends in Product Promotion- A two part series” being held May 30-31, 2012. In each 90-minute session Partner Alan Minsk, of the Food and Drug Practice Group will discuss some of the recent FDA regulatory trends in pharmaceutical and medical device product promotion.  Each session will address areas where the Firm receives questions from clients and will conclude with a Q & A session. The program is not intended to serve as an advertising/promotion 101-type of program; a basic understanding of current regulatory requirements is expected. 

First Session
Wednesday, May 30, 2012 from 11:30 am – 1:00 pm EDT

Topics to be discussed in the first session include:

  • Product discussions in the pre-approval phase
  • Medical booths and exhibit halls
  • Oral statements
  • FDA’s guidance on responding to unsolicited requests for off-label information
  • Dissemination of White Papers and medical literature

Second Session
Thursday, May 31, 2012 from 11:30 am – 1:00 pm EDT

Topics to be discussed in the second session include:

  • FDA’s last guidance on direct-to-consumer advertisements for prescription drugs
  • General vs. specific use claims for medical devices
  • Comparative claims
  • FDA and social media (e.g., company-sponsored apps, Twitter, Facebook, and YouTube)
    • Both sessions have been approved for 1.5 hours of State Bar of Georgia CLE credit.  If you have any questions please contact Tracey Chapman at