Do you want to make sure that your company or clients understand the complicated FDA regulations for advertising and promoting pharmaceutical products? The third edition of FDLI’s best-selling Off-Label Communications: A Guide to Sales & Marketing Compliance is a comprehensive, practical guidebook on how to comply with the often changing world of off-label regulation, litigation and policy.
This user-friendly resource provides critical updates from industry experts since the release of the second edition in 2009. It includes important, must-read chapters on past and current regulations; civil and criminal penalties of off-label promotion; pitfalls of clinical trials and Medicare and Medicaid reimbursement; product liability risks; and training of sales and marketing personnel. New to the third edition is a chapter focused exclusively on Comparative Effectiveness Research and expanded content on the First Amendment.
||Edited by Mark Carlisle Levy
|Number of pages:
||Sep 21, 2012