Investigational New Drug Application

An Investigational New Drug Application (INDA) is an application filed with the FDA. It is the first step a drugmaker must take before it is allowed to run clinical trials with the proposed compound.

Expanded Definition

An INDA with the FDA is a prerequisite to the institution of human trials in the Unites States.

Before filing an INDA, the drug developer must first identify a compound with potential medical benefits by screening compounds for activity against a particular target in the body. They typically run trials in the test tube and/or in animal models to gather evidence for the theory that it might be effective in humans before advancing to human trials.

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