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Introduction
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What FDA Regulates
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Clarifying the "new" in IND
Assessing Preclinical Data
Properties of the Study Drug
How the Data is Used
IND Submission
IND Holder Reponsibilities

IND Submission Process

The purpose of the IND Submission is to gain FDA non-objection to studying the investigational agent in humans. The IND Submission to the FDA is prepared using FDA Forms 1571 and 1572.

Information required includes:

  • Sufficient preclinical data, including toxicity data
  • Details of the chemistry, manufacturing and controls to provide adequate quality control information for the production of the agent and to describe the mechanism of action of the agent
  • Background and rationale for intended clinical use
  • Proposed protocol for Phase I human use

Upon receipt of the IND submission by the FDA, the investigator may proceed with the clinical study 30 days after the receipt date on the FDA’s IND acknowledgement letter (unless notified by FDA not to begin the study) OR on receipt of an IND approval letter from FDA.

The IND Submission Template provides essential elements, guidance, and a formatted document in which to prepare an IND submission to the FDA.
Download IND Submission Template here