Investigational New Drug (IND)

An Investigational New Drug (IND) is a new (biological) drug used in clinical investigations but not yet approved for marketing by the FDA. Federal law requires an approved marketing application for a drug to be transported or distributed across state lines. However, sponsors often need to ship investigational drugs to clinical investigators in various states, requiring an exemption from this legal requirement. The IND application provides this exemption from the FDA.

In early preclinical development, the sponsor ensures the product is safe for initial human use and has promising pharmacological activity. Once identified as a viable candidate, data is collected to confirm it won’t pose unreasonable risks in early-stage clinical studies. When ready for human testing, the product is classified as a new drug under the Federal Food, Drug, and Cosmetic Act, adhering to specific regulatory requirements.

There are three types of INDs:

Investigator IND: Submitted by a physician who initiates and conducts the investigation.
Emergency Use IND: Allows the FDA to authorize the use of an experimental drug in emergencies.
Treatment IND: Submitted for experimental drugs showing promise in clinical testing for serious conditions.

INDs fall into two categories: commercial (submitted mainly by companies) and research (non‑commercial; submitted mainly to advance scientific knowledge).

The IND application must include:

Animal pharmacology and toxicology studies
Manufacturing details
Clinical protocols and investigator qualifications

Once submitted, the sponsor must wait 30 days for the FDA to review the IND for safety before starting clinical trials.