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:
“Behind the steering wheel
The boy took out his own forehead.
His girlfriend’s head was a green bag
Of narcissus stems. “OK you win
But meet me anyway at Cohen’s Drug Store
In 22 minutes.””
—John Ashbery (b. 1927)
“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)
“What is rational is actual and what is actual is rational. On this conviction the plain man like the philosopher takes his stand, and from it philosophy starts in its study of the universe of mind as well as the universe of nature.”
—Georg Wilhelm Friedrich Hegel (1770–1831)