Definition

A submission to the FDA to request permission to ship and administer an investigational drug in the United States. The IND provides data supporting that the drug is reasonably safe for initial human testing.

Example

A sponsor submits an IND with chemistry, nonclinical, and clinical protocol information before starting Phase 1 trials in the US.

Regulatory source

21 CFR 312, FDA Guidance

Common mistakes

Confusing IND (US) with CTA (EU). Starting clinical trials in the US before IND is in effect (30-day default).

Inspector question

How do you ensure the IND is in effect before dosing the first subject? What is your 30-day wait process?

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