Drug Efficacy Study Implementation

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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 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, uneffective, or needing further study.

The DESI program was a consequence of the Kefauver-Harris Drug Control Act.

See also

• Regulation of therapeutic goods
• Federal Food, Drug, and Cosmetic Act
• Estes Kefauver

External links

• Drug Efficacy Study Implementation (DESI) page at the FDA's Center for Drug Evaluation and Research (CDER) website.
• The Drug Efficacy Study of the National Research Council’s Division of Medical SciencesTemplate:US-gov-stub