IND

An Investigational New Drug (IND) is a drug or biological product that has not been approved for general use by the Food and Drug Administration (FDA). It is used in a clinical trial to investigate its safety and efficacy.

Types of INDs

• Commercial INDs are filed by companies to obtain marketing approval for a new drug.
• Research or investigator INDs are non-commercial INDs filed by researchers to study an unapproved drug or to study an approved drug for a new indication or in a new patient population.
• Emergency Use INDs, also called compassionate use or single-patient INDs, are filed for emergency use of an unapproved drug when the clinical situation does not allow sufficient time to submit an IND in accordance with 21 CFR §§ 312.23, 312.24. These are most commonly used for life-threatening conditions for which there is no standard treatment.
• Treatment INDs are filed to make a drug available for treatment of serious or immediately life-threatening conditions prior to FDA approval. Serious diseases or conditions are stroke, schizophrenia, rheumatoid arthritis, osteoarthritis, chronic depression, seizures, Alzheimer’s dementia, amyotrophic lateral sclerosis (ALS), and narcolepsy.
• Screening INDs are filed for multiple, closely related compounds in order to screen for the preferred compounds or formulations. The preferred compound can then be developed under a separate IND. Used for screening different salts, esters and other drug derivatives that are chemically different, but pharmacodynamically similar.