Publisher Summary This chapter provides an overview of the FDA, and the regulation of human drug and biological products. The mission of the FDA is to protect and enhance the public health through the regulation of medical products and food. The FDA regulates medical products throughout their life cycle to help ensure the quality of the product, the protection of human subjects in clinical trials, and the safety and effectiveness of marketed medical products. The FDA is responsible for the review of regulatory submissions, the development and implementation of regulatory policy, research and scientific exchange, product surveillance, and compliance. FDA strives to facilitate the development of new safe and effective medical products while ensuring the safety of the products and its uses. The FDA regulates these products based on sound science, law, and public health.