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 are serious indeed. In this audio conference, our speakers provide background information and examine the current regulatory status of off-label promotion of drugs and 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 life sciences companies by FDA, and the roles of the Office of the Inspector General, U.S. Attorney's Office and state governments.
Off-Label Information: Regulation & Dissemination is being presented by Caryn Silverman & Soo Kim, Partner & Senior Associate, with Sedgwick, Detert, Moran & Arnold LLP and airs on Thursday, September 3, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com
