a form submitted by a company as a request for FDAis permission to expose healthy human volunteers to an experimental drug; must be filed for each clinical trial performed, phases 1-3.
After completing preclinical testing, a company files an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration to begin to test the drug in humans. The IND becomes effective if FDA does not disapprove it within 30 days. The IND shows results of previous experiments; how, where and by whom the new studies will be conducted; the chemical structure of the investigational drug; how it is thought to work in the human body; any toxic effects found in the animal studies; and how the compound is manufactured. All clinical studies must be reviewed and approved by the Institutional Review Board (IRB) or where the studies will be conducted in Europe, the Independent Ethics Committee (IEC)
The FDA approval process begins with an Investigational New Drug (IND) Application which contains all the preclinical studies conducted using the drug, as well as chemistry and manufacturing data. These include safety and toxicology studies using the drug in animals, and any efficacy studies that have been conducted in animals. Thirty days after submission, if the company has received no questions or requests for further information, the company may begin Phase I studies in humans.