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Investigational New Drug Application (IND)
Practical Law Glossary Item w-001-0450 (Approx. 2 pages)
Glossary
Investigational New Drug Application (IND)
An application to the Food and Drug Administration (FDA) for human clinical studies of an unapproved drug or biologic. An Investigational New Drug Application (IND) is a request for an exemption from the Food, Drug, and Cosmetic Act's prohibition against introducing an unapproved drug into interstate commerce. An IND must provide the FDA with enough information for it to conclude that the proposed human study is reasonably safe. The study cannot begin until the IND goes into effect 30 days after its submission, unless the FDA objects.
Among other things, an IND must include:
- Preclinical, pharmacological, and toxicological data to demonstrate that the drug is reasonably safe to test in humans.
- Information on the drug's chemistry, manufacturing, and controls.
- A protocol for a proposed clinical study the qualifications of the investigators conducting it.