Written by the most experienced food and drug attorneys in the United States and edited by four of the most distinguished authorities in the field, Food and Drug Law and Regulation is one of the most comprehensive guidebooks ever published covering an area that accounts for more than 20 percent of all consumer spending in the United States. Equally relevant to practicing food and drug attorneys, in-house drug, device, biologics, cosmetics, food and tobacco counsel, consultants, law professors and students, this unique, 26-chapter treatise explores the Food and Drug Administration's vast and complex regulatory systems and standards--everything from food safety, to prescription drug promotion, to combination products, to tobacco deeming regulations, and the medical device 510(k) process. The book includes valuable information on FDA's administrative and enforcement authority as well as the agency's role in addressing bioterrorism, international issues, and the practice of medicine. This resource also contains the latest need-to-know information on new statutes, regulations, guidances and caselaw.