Investigational New Drug
Investigational New Drug (IND)
Investigational New Drug (IND) /ɪnˈvɛstɪˌɡeɪʃənəl njuː drʌɡ/ is a term used in the pharmaceutical industry to denote a medication or biological product that has not yet been approved by the Food and Drug Administration (FDA) for public use.
Etymology
The term "Investigational New Drug" originates from the regulatory process in the United States where a drug is classified as "investigational" while it is being studied in clinical trials to determine its safety and efficacy.
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 public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices.
- Pharmaceutical industry: The commercial industry that discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications.
- Biological product: A product such as a vaccine, blood product, or allergenic that is used to prevent, treat, or cure diseases and medical conditions.
- Drug approval process: The process drugs must go through before they can be marketed to consumers.
See Also
- New Drug Application (NDA)
- Biologics License Application (BLA)
- Therapeutic Goods Administration (TGA)
- European Medicines Agency (EMA)
External links
- Medical encyclopedia article on Investigational New Drug
- Wikipedia's article - Investigational New Drug
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