New FDLI Publication Releases
A Practical Guide to Food and Drug Law
and Regulation - 3rd Edition
The Third Edition of A Practical Guide to Food and Drug Law and Regulation has been significantly updated and revised from the Second Edition, including incorporation of the Food and Drug Administration Amendments Act and other new laws passed since 2002. It also includes three new chapters: Combination Products, Pharmacovigilance and Regulation of Medical Research. A Practical Guide remains the single best resource for anyone needing a basic, uncomplicated understanding of the myriad requirements enforced by the Food and Drug Administration.
PRICE
$99 Member | $149 Non-Member
Expected to ship in September
FDCA Statutory Supplement, including all the FDA Amendments Act of 2007 and Related Sections of Additional Statutes
The FDCA Statutory Supplement incorporates all the latest revisions to the Food, Drug, and Cosmetic Act including the FDA Amendments Act of 2007. This comprehensive and fully integrated text is the most up-to-date version available, which is equally useful to both students and practitioners alike. A must for your bookshelf.
PRICE
$79 Member | $99 Non-Member
Off-Label Communications:
A Guide to Sales & Marketing Compliance
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.
PRICE
$99 Member | $149 Non-Member
Expected to ship in September