Drug Efficacy Study Implementation

FDA becomes part of the Public Health Service (PHS). The Drug Efficacy Study Implementation (DESI) is FDA s response to the investigation on the effectiveness of drugs. 

US Department of Health, Education and Welfare, Food and Drug Administration. Certain estrogens for oral or parenteral use. Drugs for human use. Drug efficacy study implementation. Federal Register 1971 36(217) 21537-8. 

The requirement that drugs be both effective and safe did not become law until 1962. The Kefauver-Harris amendment to the Food, Drug, and Cosmetic Act passed in 1962 required the FDA to review all drugs released after 1938 for effectiveness as well as safety. This program established the Drug Efficacy Study Implementation (DESI) and the job was assigned to the National Academy of Sciences—National Research Council, which reviewed the data presented for each drug that had been submitted to the FDA. 

On the basis of the Drug Efficacy Study Implementation (DESI) review, which began in 1962, the FDA... 

Drug Efficacy Study Implementation Notice (FDA, to evalu ate drugs in use before 1962)... 

For a drug product that was approved prior to 1962 and is determined to be effective in at least one indication in a Drug Efficacy Study Implementation (DESI) notice and is listed not to have a potential bioequivalence problem. 

E. DESI (Drug Efficacy Study Implementation Program)... 

---