The Food and Drug Administration (FDA) is the regulatory authority responsible for public health in the United States. It operates under the U.S. Department of Health and Human Services and is responsible for the safety and efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics, and radiation-emitting products.
In the context of clinical trials, the FDA is the central authority that decides on the approval of new drugs and medical devices for the U.S. market. It reviews data from preclinical and clinical studies to ensure that the benefit of a new product outweighs its risks. The FDA establishes strict regulations for the conduct of clinical research, such as Good Clinical Practice (GCP) and the regulations in 21 CFR. For any CRO operating globally, precise knowledge and compliance with FDA regulations is of critical importance to enable successful regulatory submissions for their clients.