The course will provide an overview to the FDA regulatory processes regarding the evaluation and development of drug, biologics and device products. Through interactive lecture format, course work and discussions, participants of this course gain the basic understanding, and become familiar with the current principles of regulatory affairs. Topics include the historical development of U.S. drug laws, overview of drug, biologics, and device development process and the FDA, pharmaceutical industry-FDA functions and interactions through approval and monitoring processes, policy-guided science, and some examples of the development of U.S. drug/device laws, shaping history, leading into the present state of regulation.