ABSTRACT
Historically, the process of new drug evaluation and approval has evolved so that drugs are proven to be both safe and effective in order to comply with increasing levels of regulatory oversight. In the United States, the first regulations imposed were decreed by the Pure Food and Drug Act of 1906, which required accurate labeling of medicines and listing of “addictive and/or dangerous” substances such as morphine, cannabis, and alcohol. The issue of safety was addressed further in 1938 with the passage of the Food, Drug, and Cosmetic Act.
