is being presented by Caryn Silverman, Partner, with Sedgwick, Detert, Moran & Arnold LLP and airs on Thursday, June 3rd, 2010. For more details or to register please visit our site at www.fxconferences.com
Off-label promotion is a perennial hot topic within the life sciences. The rules can appear ambiguous at times, but the consequences of running afoul of FDA and other enforcement authorities are serious indeed. In this audio conference, our speaker provides background information and examines the current regulatory status of off-label promotion of medical devices. The presentation also looks at the "how-tos" for dissemination of off-label information; the role of sales representatives and medical science liaisons (MSLs), and the practical application of the FDA's January 2009 guidance on reprints.
This session also examines the consequences of off-label promotion, reviews some actual enforcement actions taken against medical device companies by FDA, and the roles of the Office of the Inspector General, U.S. Attorney's Office and state governments.
