Blog / Article / Regulatory

What is the Purpose of an IND?

July 15, 2017
An investigational new drug (IND) is one that has shown promise in laboratory testing and is ready for clinical trials. Drug development takes a very precise course that is overseen and regulated by the FDA. Initial drug development begins with research and synthesis. The resulting compound is tested in the lab to be sure it is safe to try on people.

With favorable lab results, the drug company or a sponsor, like the National Cancer Institute, completes an IND application asking the FDA to clear their potential new drug for clinical testing. During the application process, the FDA reviews the lab results to determine if the drug shows any treatment potential and can be tested in people with a reasonable degree of safety.

A commercial IND is not cleared for sale, only to be used in clinical trials. FDA approval is required to bring a drug to market, and that application comes after the clinical trials are completed. The FDA issues other types of INDs, including treatment or emergency. A doctor may request permission from the FDA to treat a patient with an investigational new drug before the clinical trials are complete if they feel the patient cannot wait for final approval. An emergency IND is issued under similar circumstances when the situation is life and death.

The Purpose of an IND

FDA approval is needed to bring a new drug to market, and IND is a preliminary step in that process. It is against federal law to transport an unapproved, unlabeled drug across state lines. Most clinical trials require participation from patients in various locations, and that pre-supposes sending the new drug to various states. An IND is exempt from this distribution restriction.

An IND can also be used for early permission to use a drug for treatment. Once a drug enters the clinical research phase, it is deemed safe for people with reasonable certainty. Although it is not legal to sell a drug at this point, some patients may not be able to wait for final approval.

Doctors can apply for permission to use an IND to treat a specific patient if they can demonstrate to the FDA that the risk of waiting for final approval would out-weigh any potential risks from the drug itself.

Move your drug forward, faster with TD2.

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