Every drug, medical device, diagnostic test, and food sold in the U.S. meets a rigorous set of standards that is intended to ensure products meet a set of safety and performance objectives. When products are transported across state lines, the U.S. Food and Drug Administration (FDA) has been given the authority through federal law (Code of Federal Regulations) to oversee sponsors producing these products. Both governmental agencies and industry sponsors must adhere to these codes.Because science and technology are moving at an ever-increasing pace, the food, drug and medical and diagnostic device industries must ensure that quality and regulatory requirements are met. Scientists must possess the knowledge and expertise to understand the environment encompassing regulatory compliance. Other essential skills include project management and leadership, scientific tools that allow for proper risk assessment and risk management strategies, and the ability to identify and use clear communication practices to convey essential information to technical and non-technical audiences.The Regulatory Affairs Track at the Yale School of Public Health (YSPH) represents a graduate-level standard in training Masters students. All lectures will adhere to widely accepted regulatory principles, from governmental and industry sponsor viewpoints. This Track prepares students for roles in the area of regulatory affairs. The Track is necessarily multi-disciplinary, to reflect the full array of issues that one may face in regulatory affairs science, including complex issues involving food and drug law, ethics, clinical trials, epidemiology, risk analysis and leadership. Most of these areas of expertise reside within YSPH and Yale more broadly.