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U.S. Investigational New Drug Application

Overview
What is an IND Application?
An IND application is the formal request for FDA authorization to conduct human research on a substance believed to have medical actions.

An IND’s main purpose is to ensure that a drug candidate does not pose unreasonable risk to participants in the context of early-stage clinical studies. This application follows screenings for potential for toxicity and for pharmacologic activity in animals, and indicates the sponsor is ready to proceed in to human studies.

What does an IND Application allow?
The IND application allows the sponsor to begin human trials. The IND also exempts a drug product from the FDA’s legal requirement that drugs without FDA approval cannot be shipped across state lines. This exemption allows the sponsor to ship their drug product across state lines to investigators that will be taking part in clinical studies.

Learning Objectives:

  1. Describe the types of IND applications
  2. List the components required to be included in an IND and identify who files these applications
  3. Review the overall IND application process
  4. Briefly describe the timeline and possible FDA responses to an IND application