Investigational New Drug (IND)

What

What is an IND?

An Investigational New Drug (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Following preclinical benchwork, conducting investigations under an IND is the first step to getting a new drug approved for marketing by the FDA.

What is a Drug?

A substance recognized by an official pharmacopoeia or formulary.
A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
A substance (other than food) intended to affect the structure or any function of the body.
A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process.)

Non-traditional medical interventions that also require an IND:

Live Organisms
Dietary Supplements (if used in a therapeutic context)

Why

Why do I need an IND?

An IND is required by law per FDA Regulation (Title 21 of the Code of Federal Regulations (CFR), Part 312 (21 CFR 312)

Failure to comply may result in termination of research, warning letters from federal agencies (posted on FDA website), disqualifications/ restrictions/ debarments (posted on FDA website), criminal prosecutions, prison, and/or fines.

Which

Do I Need an IND?

Does your research involve:

1. A drug/biological product or investigational device?

2. Is the drug/product/device used in a clinical research investigation with human subjects?

3. Did you/your collaborators (non-industry) design the study?

If you answer yes to all questions above, you probably need an investigator-sponsored IND.

When

When Do I Start an IND Application?

See eIRB, IND/IDE, CT.gov clinical trial reporting timeline

Who

Who needs to submit the IND?

The Sponsor needs to submit the IND. This will be the Sponsor-investigator physician for an investigator initiated study.

Who is the Sponsor?

An individual, company, academic institution or other organization that takes responsibility for and initiates a clinical investigation

Who is the Investigator?

An individual who conducts a clinical trial, i.e. under whose immediate direction a drug is administered or dispensed

Who is the Sponsor-Investigator?

An individual who both initiates and conducts an investigation

How

IND Quick Guide

List of regulatory components for initial IND applications as outlined by FDA

Initial IND Submission Process

1. Determine whether an IND is required (Schedule a one-on-one consultation!)

2. Prepare IND Application (use below templates)

3. Material Review (SI Support staff review applications)

4. Submit IND application to FDA

IND Templates, Guidance and Useful Links

IND Submissions

IND Guidance from the FDA

FDA Form 1571 - IND Application*

FDA Form 1572 - IND Investigator Statement*

FDA Form 3674 - IND Certification of Compliance*

FDA Form 3454 - Certification: Financial Interests and Arrangements of Clinical Investigator*

FDA Form 3455 - Investigator Financial Interest Disclosure*

IND Initial Application Template

IND Initial Application Cover Letter

*If when opening these forms you see the ‘Please wait’ page, download and open with Adobe Acrobat to use the form

Need assistance or have regulatory questions? Please SIsupport@UTSouthwestern.edu