ABSTRACT
This introduction presents an overview of the key concepts discussed in the subsequent chapters of this book. The book argues that virtually all commercial products have to meet regulatory toxicology requirements in their approval for market entry, manufacturing, distribution, and disposal. It focuses on the global regulations and regulatory bodies, though an emphasis on the United States, the European Union, and Japan remains. While the emphasis is on the regulations involved in causing testing to occur for product safety and environmental and manufacturing practices, there are other regulations that govern the manner in which this information is generated or gathered. The book discusses the roles of the Food and Drug Administration in the regulation of human pharmaceuticals, biologics, and medical devices, veterinary drugs, food additives, and cosmetics. It focuses on the consumer products.
