An Investigational New Drug is a new drug or biologic used in a clinical investigation.
In general, the submission of an Investigational New Drug (IND) application is required for any clinical research study that proposes the use (e.g., as a research tool to explore a biological phenomenon or disease process) or evaluation (i.e., for safety and/or effectiveness) of an unapproved drug.
An Investigational New Drug is a new drug or biologic used in a clinical investigation.
In general, the submission of an Investigational New Drug (IND) application is required for any clinical research study that proposes the use (e.g., as a research tool to explore a biological phenomenon or disease process) or evaluation (i.e., for safety and/or effectiveness) of an unapproved drug.
One of the FDA's primary mechanisms for ensuring the safety of research subjects is through Investigational New Drug (IND) filing requirements. The term IND can be misinterpreted, leading researchers to inaccurately conclude that if the drug they are studying is already approved by the FDA, it is not a "new" drug needing a IND application to be filed.
A study that uses a "new" aspect of the drug's use (i.e. different indication, dose, population, etc.) usually requires the filing of an Investigational New Drug Application. An IND application is a request for authorization to administer an investigational drug or biologic to humans or a marketed drug in a new indication and/or patient population.
Exceptions to the General requirements for an IND submission
If you would like to discuss your research project and the potential need for an IND, or request guidance with an IND application, please contact Amanda Wood. The NC TraCS Regulatory Service is available to assist Sponsor-Investigators with preparing IDE submissions, annual reports, supplements, and other FDA correspondence.
Through our partnership with RTI International, we can also provide pre-clinical guidance for Investigational Drug studies to facilitate thorough pre-clinical testing and trouble-free Pre-IND communications with the FDA.
Preparing an Initial IND Submission: For help, download a detailed IND submission template with instructions. NC TraCS is available to assist investigators through every step of the submission process, through the duration of the investigation, and IND closure.
The "life cycle" of an IND can involve many amendments formal reports over the course of an investigation. To avoid costly delays, submissions should be provided in a timely manner, and correspondence with the FDA initiated early if there are questions.
IND Holder Responsibilities: Once an IND is submitted, the IND Sponsor-Investigator is responsible for:
The IND holder must notify the FDA of any of the following:
Protocol Amendments
Any changes to the protocol or any new protocols using the investigational agent
Any new sub-investigators or changes to investigators (with a revised FDA Form 1572)
Safety Data
IND Safety Reports
IND Annual Reports (includes a summary of all study findings and adverse events to date)
Investigational Drug Updates
Any changes to the chemistry, manufacturing, and controls
Changes to the Investigational Brochure
Closing Out the IND
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