A Practical Guide to Food and Drug Law and Regulation

Tables of Contents "Overview of the U.S Legal System. U.S Food and Drug Law and FDA - A Historical Background. The philosophy of Food and Drug Law. The Food and Drug Administration - How It Is Organised and Works, The Drugs/Biologics Approval Process. A Pharmacovigiilance Primer. The Medical Device Approval Process. Combination Products. The Cosmetics Regulatory Process, The Regulation of Foods and Food Additives. The Regulation of Dietary Supplements. Regulation of Promotion and Distribution. Review of FDA Inspections and Related Regulations. FDA Enforcement: How It Works, Being Prepared. Research and the FDA. International Regulation. Fundamental Issues Facing 21st Century Regulation.No Dust Jacket, illustrated paperback (as image shown on ABE) some creases on back corner of cover, otherwise clean tight copy in very good condition, 467pp Third edition 2008 published by FDLI. Heavy item therefore ONLY available for sale in the U.K only Book#101348.