is being presented by Alan Minsk, Partner, with Arnall Golden Gregory LLP and airs on Tuesday, July 26th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Off-label promotion is a perennial focus for FDA enforcement actions, and an area of chronic concern for pharmaceutical and medical device companies. The dividing line between legitimate scientific exchange of information and off-label promotion can, at times, be somewhat blurry. It is vitally important for everyone on your team to know what can and cannot be said in the name of product promotion, and for your company to have in place a strategy to stay compliant.
In this audio conference, our speaker reviews the regulations concerning product promotion in the life sciences, sharing experience and insight on some of the red-flag areas likely to attract unwanted attention from FDA. The presentation looks at the Good Reprint Practices guidance, and what it does and does not say about sharing off-label information. It also discusses the role of medical affairs and the medical science liaison, and reviews factors to consider when determining what is and is not acceptable promotional activity.
