Drugs, biologics and devices increasingly are used to treat patients in ways that were not specifically approved by FDA. While FDA does not regulate off-label use nor forbid off-label prescribing, it does heavily regulate off-label promotion. This book provides comprehensive, practical advice on how to comply with those regulations. This guide gives a valuable historical perspective on off-label medicine. The authors discuss specific problems arising from off-label use and promotion, while providing practical instruction on how to deal with them, including: managing clinical trial disclosures; reimbursement; training and monitoring sales and marketing representatives; risk management; product liability litigation; ethical considerations and how the government is enforcing off-label sales and marketing compliance.