Drug Efficacy Study Implementation (DESI) was a program begun by the Food and Drug Administration (FDA) in the 1960s after the requirement (in the Kefauver-Harris Drug Control Act) that all drugs be efficacious as well as safe. The DESI program was intended to classify all pre-1962 drugs that were already on the market as either effective, ineffective, or needing further study. The Drug Efficacy Study Implementation (DESI) evaluated over 3000 separate products and over 16,000 therapeutic claims. By 1984, final action had been completed on 3,443 products; of these, 2,225 were found to be effective, 1,051 were found not effective, and 167 were pending.
One of the early effects of the DESI study was the development of the Abbreviated New Drug Application (ANDA).
Famous quotes containing the words drug, efficacy and/or study:
“If an addict who has been completely cured starts smoking again he no longer experiences the discomfort of his first addiction. There exists, therefore, outside alkaloids and habit, a sense for opium, an intangible habit which lives on, despite the recasting of the organism.... The dead drug leaves a ghost behind. At certain hours it haunts the house.”
—Jean Cocteau (1889–1963)
“For books are not absolutely dead things, but do contain a potency of life in them to be as active as that soul was whose progeny they are; nay, they do preserve as in a vial the purest efficacy and extraction of that living intellect that bred them. I know they are as lively, and as vigorously productive, as those fabulous dragon’s teeth; and being sown up and down, may chance to spring up armed men.”
—John Milton (1608–1674)
“Though those who study are as many as the number of hairs on an ox, those who succeed are as rare as unicorns’ horns.”
—Chinese proverb.