ABSTRACT
Requirement for drug safety evaluation as we now know it started in the 1937 due to fatalities associated with reformulation of an existing over-the-counter product (elixir of sulfanilamide) and the subsequent passage of the U.S. Food Drug and Cosmetic Act. The requirement for prenotification of the U.S. Food and Drug Administration (FDA) that a drug was going to be tested in humans [an investigational new drug (IND)] and a structured program of nonclinical safety studies, however, did not arise until 1963 following the thalidomide disaster. This entry discusses the safety regulations in drug development and examines the strategies for their development, toxicity testing, and nonclinical as well as clinical data analysis.
