ABSTRACT
In response to the thalidomide tragedy, the United States (US) Congress passed the Kefauver-Harris Amendment to the 1938 Federal Food, Drug, and Cosmetic Act in 1962 (Krantz, 1966). The Amendment required drug manufacturers to prove the effectiveness and safety of their drugs in adequate and well-controlled investigations before receiving marketing approvals. In the years following the Amendment, the Food and Drug Administration (FDA) in the US issued various regulations to help implement the new law. For example, the FDA had to define the characteristics of adequate and wellcontrolled clinical investigations (trials) and devise a review system that is evidence based, legally sound, and understood by industry (Anello and Junod, 2013).
