Drug Efficacy Study Implementation


Drug Efficacy Study Implementation -DESI- (in Spanish Implementation of the Study of the Efficacy of Drugs) was a program initiated by the Food and Drug Administration (FDA) in the 1960s after it was required (in the Law of Drug Control Kefauver-Harris) that all medications be effective and safe. The DESI program intended to classify all drugs that were already on the market prior to 1962, as effective, ineffective, or in need of further studies. More than 3,000 different products and more than 16,000 therapeutic claims were evaluated. In 1984, all evaluations had been completed in 3 443 products, of which 2,225 were effective, 1,051 were ineffective, and 167 were in the process of being studied. One of the first effects of the DESI study was the development of the Abbreviated New Drug Application -ANDA- (Abbreviated new drug application).

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