ABSTRACT
INTRODUCTION The Federal Food, Drug, and Cosmetic Act (FD&C Act) is the basic food and drug law in the Unites States. It requires that “new drugs,” as defined by the Act, be reviewed and approved by the U.S. Food and Drug Administration (FDA) before they go on the market. In 1938, the FD&C required that the drug manufacturers file a new drug application (NDA) with the FDA for each newly introduced drug and submit evidence to support safety of the drug product. Subsequently, the act has been amended on a number of occasions. A few landmark amendments that influenced the way the FDA approves drugs include the 1951 Durham-Humphrey Amendments (firmly establishing the concept of “prescription” drugs), the 1962 Kefauver-Harris Amendment, the Orphan Drug Act of 1983, and the Drug Price Competition and Patent Term Restoration Act of 1984 (also known as the “Hatch-Waxman Amendments”).
