Blog / Article / Regulatory

What are the Types of INDs?

September 15, 2017
Types of IND Applications

A potential new drug needs IND approval to enter the clinical investigation part of development. IND approval must be completed before the new drug application can be submitted for approval to market to doctors and patients. IND applications must contain three types of information:

With a completed application, the FDA has up to 30 days to review this information and issue an IND. After that, clinical trials can begin.


Types of INDs

An IND is required in the development of a new drug, but there are other types of INDs issued by the FDA:

Emergency Use IND — The FDA may authorize the use of an experimental drug for patients who do not fit the study criteria or as treatment in a life-threatening situation when there is no time to wait for an IND.

Investigator IND — Submitted by a doctor for research on an un-approved drug or a new indication for an approved drug. The FDA approves the doctor who submitted this application to administer the drug and conduct the investigation.

Treatment IND — this allows an experimental drug to be used to treat a patient while the FDA is conducting its review of the drug. It is only approved for serious or life-threatening conditions.

Move your drug forward, faster with TD2.

Contact Us Today
Get free tips, tools and resources by subscribing to the TD2 Newsletter: