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:
“Narcotics have been systematically scapegoated and demonized. The idea that anyone can use drugs and escape a horrible fate is an anathema to these idiots. I predict that in the near future, right wingers will use drug hysteria as a pretext to set up an international police apparatus.”
—Gus Van Sant, U.S. screenwriter and director, and Dan Yost. Father Tom Murphy (William S. Burroughs)
“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)
“Gonna lay down my burden
down by the riverside,
to study war no more.”
—Unknown. “Down by the Riverside,” l. 5-7.
Based on Isaiah 2:1-5.