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. 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 3,000 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.
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- Drug Efficacy Study Implementation (en)
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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. 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 3,000 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. (en)
- Drug Efficacy Study Implementation —DESI— (en español Implementación del Estudio de la Eficacia de los Medicamentos) fue un programa iniciado por la Food and Drug Administration (FDA) en la década de 1960 después que se requiriera (en la Ley de Control de Drogas Kefauver-Harris) que todos los medicamentos fueran eficaces y seguros. El programa DESI tenía la intención de clasificar a todos los medicamentos que ya estuvieran en el mercado previo a 1962, como eficaces, ineficaces, o con necesidad de más estudios. Se evaluaron más de 3 000 productos diferentes y más de 16 000 demandas terapéuticas. En 1984, se había completado todas las evaluaciones en 3 443 productos, de los cuales 2 225 resultaron ser efectivos, 1 051 ineficaces, y 167 en proceso de estudio. Uno de los primeros efectos de la (es)
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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. 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 3,000 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). (en)
- Drug Efficacy Study Implementation —DESI— (en español Implementación del Estudio de la Eficacia de los Medicamentos) fue un programa iniciado por la Food and Drug Administration (FDA) en la década de 1960 después que se requiriera (en la Ley de Control de Drogas Kefauver-Harris) que todos los medicamentos fueran eficaces y seguros. El programa DESI tenía la intención de clasificar a todos los medicamentos que ya estuvieran en el mercado previo a 1962, como eficaces, ineficaces, o con necesidad de más estudios. Se evaluaron más de 3 000 productos diferentes y más de 16 000 demandas terapéuticas. En 1984, se había completado todas las evaluaciones en 3 443 productos, de los cuales 2 225 resultaron ser efectivos, 1 051 ineficaces, y 167 en proceso de estudio. Uno de los primeros efectos de la DESI el estudio fue el desarrollo de la —ANDA— (Solicitud de nuevo fármaco abreviada). (es)
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