This document summarizes the history and development of drug regulation laws in the United States from the early 1900s to present day. It describes key laws and acts that established pre-market safety testing and approval requirements for new drugs, including the Federal Food, Drug, and Cosmetic Act of 1938, Kefauver-Harris Amendments of 1962, and Prescription Drug User Fee Act of 1992. The document also provides an overview of the drug development process, including pre-clinical animal studies and three phases of clinical trials required by the FDA before a new drug can be approved.