Investigational New Drug

Also known as: IND

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Last updated

June 29, 2026

Quick Summary

An Investigational New Drug (IND) application is a crucial step in the process of getting a new drug approved for marketing in the United States. This application is submitted to the Food and Drug Administration (FDA) and is required before a new drug can be studied in humans through clinical trials.12

The IND application contains essential information about the drug's chemical makeup, dosage form, summaries of animal studies (pharmacology and toxicology), pharmacokinetic data, and any previous clinical investigations. It also includes protocols, which are detailed descriptions of the planned clinical trials.2

These clinical trials are conducted in phases (Phase 1, 2, and 3) to determine if the drug is safe and effective in humans. Before a drug can be marketed, it must successfully pass these trials and receive approval from the FDA, a process that also involves submitting a New Drug Application (NDA).3

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pharmaceutical industry
The Investigational New Drug application
Two important written documents are required from a pharmaceutical firm seeking regulatory approval from the U.S. FDA. The first is the Investigational New Drug (IND) application. The IND is required for approval to begin studies of a new drug in humans.…
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Two important written documents are required from a pharmaceutical firm seeking regulatory approval from the U.S. FDA. The first is the Investigational New Drug (IND) application. The IND is required for approval to begin studies of a new drug in humans.…
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…vaccines are still in the Investigational New Drug (IND) category and await further trials before the Federal Drug Administration (FDA) can validate their effectiveness and safety. Included among these are vaccines for Q fever, tularemia, Venezuelan equine encephalitis, viral hemorrhagic fever, and botulism.
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therapeutics
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Before an investigational new drug (IND) can be tested in humans, it must be submitted to and approved by the FDA. If clinical trials are successful, a new drug application (NDA) must be approved before it can be licensed and sold. This process usually takes years, but…
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Before an investigational new drug (IND) can be tested in humans, it must be submitted to and approved by the FDA. If clinical trials are successful, a new drug application (NDA) must be approved before it can be licensed and sold. This process usually takes years, but…
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