Investigational new drug
Investigational New Drug (IND)
Investigational New Drug (IND) /ɪnˈvɛstɪˌɡeɪʃənəl njuː drʌɡ/ is a term used in the pharmaceutical industry to describe a new drug substance or an old drug substance used in a new manner for which approval for marketing in the United States has not yet been obtained.
Etymology
The term "Investigational New Drug" is derived from the phrase "investigate" which means to carry out a systematic or formal inquiry to discover and examine the facts so as to establish the truth. The term "new drug" refers to a substance that has not been approved for use in the market.
Related Terms
- Clinical trial: A research study that tests how well new medical approaches work in people.
- Food and Drug Administration (FDA): The federal agency responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs.
- New Drug Application (NDA): An application submitted by the manufacturer of a drug to the FDA - after clinical trials have been completed - for a license to market the drug for a specified indication.
- Biologics License Application (BLA): A request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.
- Orphan drug: A pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance.
See Also
External links
- Medical encyclopedia article on Investigational new drug
- Wikipedia's article - Investigational new drug
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