Investigational New Drug (IND) application Investigational New Drug (IND) application
An application to the United States Food & Drug Administration (FDA) to get permission to use a drug in a research study that enrolls people.
Example of Investigational New Drug (IND) application in a sentence
Researchers submit an Investigational New Drug application to the FDA to get permission to study a new use for a drug.
More Info
The Investigational New Drug (IND) application is specific to the United States (US). Researchers testing a new drug, or an approved drug for a new use, must get approval of an IND from the US Food and Drug Administration (FDA). The FDA is a government agency that regulates drugs and devices that are used in patients. Once approval is obtained, the research is often said to be conducted “under an IND.”
Similar processes exist elsewhere in the world. For example, in Europe approval is obtained via a Clinical Trial Application (CTA).
Other info to think about when joining a study
If you join a study that is testing a medicine under an Investigational New Drug (IND) application you should feel free to ask about what safety information about the study treatment is already known, and why this particular medicine is being tested. You can also find out more about the risks and what kind of care you can expect to receive if there are any adverse events.
