Investigational New Drug Application (INDA)
An Investigational New Drug (IND) application is a submission made by a pharmaceutical company or sponsor to the U.S. Food and Drug Administration (FDA) for permission to test a new drug or biological product on humans in clinical trials.
The IND application contains information about the drug, its proposed clinical use, the manufacturing process, and the results of previous studies, including animal toxicology studies. The FDA reviews the IND application to ensure that the proposed clinical trials are safe and scientifically sound, and that the benefits of the drug outweigh the risks.
The Investigational New Drug application is a crucial step in the drug development process, as it allows the pharmaceutical company to begin testing the drug in human subjects. Without an IND application, clinical trials cannot begin. Once the IND application is approved, the drug moves into Phase 1 clinical trials, which are designed to test the drug’s safety and dosage levels in healthy volunteers or patients with the condition being studied.
Once the IND application is approved, the drug can move forward into clinical trials, which are conducted in phases to evaluate safety, dosing, and effectiveness. The results of these trials are used to support an application for FDA approval to market the drug to the public.
In summary, the IND application is important because it provides a critical pathway for evaluating new drugs in humans, which is essential for advancing medical treatments and improving public health.
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