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Investigational New Drug (IND) Application

Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. The IND is the means through which the sponsor technically obtains this exemption from the FDA. 

There are three IND types:

1. An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. 

A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.

2. Emergency Use IND allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21CFR , Sec. 312.23 or Sec. 312.20. 

It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist.

3. Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.

There are two IND categories:

  • Commercial
  • Research (non-commercial)

The IND application must contain information in three broad areas:

  • Animal Pharmacology and Toxicology Studies
  • Manufacturing Information
  • Clinical Protocols and Investigator Information

Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinicaltrials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.

The following regulations apply to the IND application process:

  • 21CFR Part 201 Drug Labeling
  • 21CFR Part 312 Investigational New Drug Application
  • 21CFR Part 314 INDA and NDA Applications for FDA Approval to Market a New Drug (New Drug Approval)
  • 21CFR Part 316 Orphan Drugs
  • 21CFR Part 50 Protection of Human Subjects
  • 21CFR Part 54 Financial Disclosure by Clinical Investigators
  • 21CFR Part 56 Institutional Review Boards
  • 21CFR Part 58 Good Lab Practice for Nonclinical Laboratory [Animal] Studies

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Resource Person: BARBARA PIROLA

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