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.
One of the early effects of the DESI study was the development of the Abbreviated New Drug Application (ANDA).
This article incorporates public domain material from websites or documents of the United States Department of Health and Human Services.