Investigational New Drug IND Definition & Meaning | Health Care Term | CSIMarket
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Glossary

Investigational New Drug IND

Health Care Term

An Investigational New Drug (IND) is a regulatory status that the US Food and Drug Administration (FDA) grants to a pharmaceutical product that is being evaluated in clinical trials. The IND is filed by the drug developer, and provides a means for the FDA to monitor the safety and effectiveness of the product during the clinical trial process.

When a drug developer has a new drug compound or biological product that they believe may have therapeutic benefit, they may file an IND application with the FDA. The IND application is a comprehensive document that includes data from animal studies, as well as any prior human trials, to support the safety and efficacy of the product. The IND application must also include a detailed plan for conducting human clinical trials, including the study design, number of patients, endpoints, and monitoring procedures.

Once the FDA receives the IND application, they have 30 days to review it and provide feedback to the developer. If the FDA determines that the IND is adequate and the proposed clinical trial does not pose an unreasonable risk to human subjects, they will allow the clinical trial to proceed.

The IND regulatory status is critical for drug developers, as it allows them to legally test their products in human subjects. Without an IND, it is illegal to conduct clinical trials of any investigational drug or biological product in the US. The IND status also provides a mechanism for ongoing communication between the drug developer and the FDA throughout the clinical trial process.

In the healthcare industry, the use of INDs is critical for the development of new therapies and treatments. The clinical trial process allows drug developers to test their products for safety and efficacy, and determine the optimal dosing and administration of the product. Successful clinical trials can lead to FDA approval of the drug, allowing it to be marketed and sold to patients. The development of new drugs and therapies is essential for improving patient outcomes and reducing the burden of disease.


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