21 CFR Part 312

21 CFR Part 312 is a section of U.S. federal regulations that governs the process of testing new drugs in people. It outlines the requirements that companies must follow to conduct clinical trials, which are research studies that assess the safety and effectiveness of new medications. The regulations ensure that patients are protected, that trials are conducted ethically, and that the data collected are reliable. Companies must submit an extensive plan to the FDA before starting trials, allowing for oversight and evaluation to ensure public safety throughout the drug development process.