ABSTRACT
The Federal Food, Drug and Cosmetic Act (FFDCA) places the responsibility for establishing the safety and efficacy of human and veterinary drugs and devices and the safety of food and color additives on the sponsor of the regulated product. The Public Health Service Act requires that a sponsor establish the safety and efficacy of biological products. These laws
place on the Food and Drug Administration (FDA) the responsibility for reviewing the sponsor’s test results and determining whether or not the results establish the safety and efficacy of the product. If the agency accepts that safety and efficacy are adequately established, the sponsor is permitted to market the product.
