Investigational New Drug Applications and Reporting Responsibilities

Do you have an investigational product ready for clinical study?

Before testing in human subjects, you may need to apply for an Investigational New Drug (IND) with the Food and Drug Administration (FDA).

This page will assist you with the application process, specifically, the Regulatory Background (21 CFR 312) and Reporting Requirements for INDs.

Ready to apply for an IND?

You can start by reviewing the reporting requirements and IND process. When you are ready to start the application process, you can download the template below.

The CTSI has support for assisting you with your application, please contact Regulatory Specialist Sheila Austin, (352) 273-8702, for assistance with the IND process and forms.

Download IND submission template here

Do you believe you meet the requirements for an IND exemption? It is recommended that you request a determination for exemption from the FDA prior to submitting your study to the IRB. By doing so, you are likely to avoid having the IRB require such a determination from the FDA as part of their review. Download the template here and contact Sheila Austin for assistance.

Reporting Requirements

Sponsors of Investigational New Drug (IND) applications are responsible for sending periodic updates and reports related to their applications to the FDA.

IND amendments and reports

Click on a button below to access the types of IND amendments and reports

FDA forms

These FDA forms may be required with IND amendments and reports:

Information about the process

All new drug development follows a common pathway. Basic research leads to conceptualization of a drug, followed by pre-clinical development involving in vitro and in vivo studies and drug prototype design. When a substance is ready for clinical study, but prior to any testing in human subjects, the drug developer must involve the Food and Drug Administration (FDA).

This process begins when the drug’s sponsor (usually the drug manufacturer or distributor) files an Investigational New Drug (IND) application with the agency. Federal law requires that a drug be the subject of an approved marketing application for it to be legally shipped across state lines. An approved IND application provides the developer with a technical exemption to this federal regulation, so that clinical investigators can distribute a drug to different study centers across the United States (Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs).

What is an Investigational New Drug (IND)?

An IND is a request for authorization from the FDA to administer an investigational drug or biological product to humans, and it:

• Notifies regulators of intent to begin clinical studies in US
• Provides preclinical data indicating that the drug is reasonably safe to administer in humans
• Provides information about manufacturing process and chemistry background
• Describes the initial clinical study being proposed
• Provides assurance that an Investigational Review Board (IRB) will approve the study before it begins

Investigators must sign commitments to:

• Conduct the clinical study in accordance with the IRB-approved protocol
• Personally conduct or supervise the conduct of the investigation
• Inform potential subjects that the drugs are being used for investigational purposes, and
• Report adverse events that occur in the course of the investigation

What qualifies as an IND?

In general, the IND regulations require that human research studies be conducted under an IND if all of the following conditions exist:

• The research involves a drug as that term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(g)(1))

Drug: articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease . . .” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Biological products may also be considered drugs

• The research is a clinical investigation as defined in the IND regulations (21 CFR 312.3)

Clinical Investigation: experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of [the IND regulations], an experiment is any use of a drug [whether approved or unapproved] except for the use of a marketed drug in the course of medical practice

• The clinical investigation is not otherwise exempt from the IND requirements in part 312

For FDA-approved drugs used off-label*

• Change in route of administration
• Change in dose
• Change in patient population

 *May be ‘exempt’ if

• Investigation not intended to be reported to FDA to support new indication/labeling change
• Investigation not intended to support significant change in advertising
• Investigation does not involve route of administration, dosage level, or population that significantly increases risk associated with use of drug
• IRB review and consent

NOTE:  UF IRB typically requires FDA IND Exemption Determination Letter to claim exemption

IND considerations:

• Is the product a Drug or Biologic? (CDER or CBER)
• What division? (Neurology products, Reproductive and Urologic products, Botanical products…)
• Would the submission benefit from a Pre-IND meeting with FDA?
• IND submission (formatting, paper or electronic, number of copies…)
• IND reporting (post granting of IND by FDA)

Questions?

Use the form below or contact CTSI Regulatory Specialist Sheila Austin, (352) 273-8702, for assistance with the IND process and forms. We are happy to answer any questions you might have.

Information provided on this page includes FDA guidance and Johns Hopkins ICTR Navigators Guidance (various) and the University of Pittsburgh.