ABSTRACT
Food and drug regulation evolved in the twentieth century, which was a reflection of major changes in the way in which foods and drugs were processed and sold. The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. Regulations are established requirements, developed by an authorized federal agency, to interpret the intent of laws. Regulations do exist for cosmetics, products that are applied externally, but have no claim of therapeutic value. Cosmetic regulations, as compared to drug rules, are relatively simple, yet they ensure these products are safe and not adulterated. The chapter focuses on the functions of FDA regulatory intelligence and a biotechnology firm’s need to continually obtain information that allows an understanding of the regulatory environment as it applies to the development of a product.
