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.
Application required by the US FDA before clinical trials of a new drug or new biological agent may be initiated. An IND is also required if the US FDA has not approved the route of administration, dosage level, or patient population for the drug or biological agent.
An application that a drug sponsor must submit to FDA before beginning tests of a new drug on humans. The IND contains the plan for the study and is supposed to give a complete picture of the drug, including its structural formula, animal test results, and manufacturing information.
The application by which a manufacturer requests that the FDA allow human testing of its drug product
an application submitted by a sponsor to the U.S. FDA prior to human testing of an unapproved drug or of a previously approved drug for an unapproved use.
The petition through which a drug sponsor requests the FDA to allow human testing of its drug product.
is an application to the U.S. Food and Drug Administration (FDA) seeking approval to begin clinical studies of a new pharmaceutical product.
An IND is a comprehensive document detailing an experimental drug's known properties. This document must be approved by the FDA before US clinical trials may begin.
A request for Food and Drug Administration (FDA) authorization to administer an investigational drug to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug that is not the subject of an approved new drug application.
A petition to the FDA to allow testing of a new drug in clinical trials.
An application submitted to the U.S. Food and Drug Administration to request authorization to initiate human clinical trials.