An application that must be submitted to a regulatory agency (the FDA in the United States) before a drug can be studied in humans. This application includes results of previous experiments; how, where, and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in animal studies; and how the compound is manufactured. (From the New Medicines in Development Series produced by the Pharmaceutical Manufacturers Association and published irregularly.)

Annotation

U.S. or foreign, but if U.S., new drug "must be submitted to the FDA" before study in humans

DUI

D017387 MeSH Browser

CUI

M0026403

Previous indexing

Drugs, Investigational (1990-1992)

History note

93

Public note

93