FDA in Clinical Trials

Clinical trial regulation is governed by the U.S. Food and Drug Administration (FDA). The FDA is responsible for ensuring the safety and effectiveness of drugs, medical devices, and biologics. Clinical trials must be conducted in accordance with FDA regulations, including the requirements of the Investigational New Drug (IND) application and the Investigational Device Exemption (IDE) application. The FDA sets standards for the design, conduct, and reporting of clinical trials. These include requirements for informed consent, ethical treatment of subjects, and reporting of adverse events. The FDA requires sponsors to submit the results of clinical trials for review and approval prior to marketing. The FDA reviews and approves study protocols, clinical trial sites, and clinical trial data. The FDA monitors clinical trial sites to ensure that the trials are conducted in accordance with FDA regulations.