This course examines the Food and Drug Administration as an administrative agency combining law and science to regulate activities affecting public health and safety. The FDA oversees a quarter of the US economy, and 40% of all products sold in the country, so legal issues abound. Topics include testing and approval of pharmaceuticals and medical devices; biologics and biotechnology regulation; genetics and genomics; pricing of and reimbursement for drugs and devices; food safety and nutritional policy; dietary supplements; cosmetics regulation; global aspects of pharmaceutical regulation; US and foreign patent issues; and FDA practice and procedure, jurisdiction and enforcement.