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. ^[1] 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.

Contents

• See also
• References
• External links

One of the early effects of the DESI study was the development of the Abbreviated New Drug Application (ANDA).

See also

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

References

External links

• National Academies of Sciences archives. The Drug Efficacy Study of the National Research Council’s Division of Medical Sciences, 1966-1969
• Chhabra, R; Kremzner, ME; Kiliany, BJ (2005). "FDA policy on unapproved drug products: past, present, and future". Ann Pharmacother. 39: 1260–4. doi:10.1345/aph.1E569. PMID   15956239.

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