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:
“While man can still his body keep
Wine or love drug him to sleep,
Waking he thanks the Lord that he
Has body and its stupidity....”
—William Butler Yeats (1865–1939)
“If there is a case for mental events and mental states, it must be that the positing of them, like the positing of molecules, has some indirect systematic efficacy in the development of theory.”
—Willard Van Orman Quine (b. 1908)
“The conscience of the world is so guilty that it always assumes that people who investigate heresies must be heretics; just as if a doctor who studies leprosy must be a leper. Indeed, it is only recently that science has been allowed to study anything without reproach.”
—Aleister Crowley (1875–1947)