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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, was made part of US law.
Donnatal® is considered part of the DESI drug category and currently is listed as one of 14 drugs still under evaluation by the FDA. [15] In response to FDA questions about Donnatal® efficacy, A. H. Robins Co. filed abbreviated new drug applications for Donnatal® tablets (ANDA 86-676), capsules (ANDA 86-677), and Elixir (ANDA 86-661). [16]
The U.S. Kefauver–Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, [1] [2] required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed ...
According to the Narcotic Drugs and Psychotropic Substances (NDPS) Act of 1985: " cannabis (hemp)" means- (a) charas , that is, the separated resin, in whatever form, whether crude or purified, obtained from the cannabis plant and also includes concentrated preparation and resin known as hashish oil or liquid hashish;
Tusi (also written as tussi, tuci, or tucibi) is a recreational drug that contains a mixture of different psychoactive substances, most commonly found in a pink-dyed powder known as pink cocaine. [ 1 ] [ 2 ] [ 3 ] It is believed to have originated in Latin America around 2018. [ 4 ]
The publication does not include drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal Tablets and Librax Capsules] or pre-1938 drugs [e.g., Phenobarbital Tablets]).
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics.
Drugs approved after June 24, 1938, but before 1962 had a limited time to be reviewed for efficacy to remain on the market. This was known as the Drug Efficacy Study Implementation (DESI). As of today there are only a handful of drugs still on the DESI list [61] and in 2006, the FDA stated it was not aware of any grandfathered drugs. [62]