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Question 7 of 20 Fundamentals Concept

What is an IND, and when can a US trial start after it is submitted?

Short answer

An investigational new drug application (IND) asks FDA for permission to give an unapproved drug to people in a US clinical investigation. It goes into effect 30 days after FDA receives it, unless FDA places the study on clinical hold or tells the sponsor earlier that it may begin.

Why

The IND carries the information FDA needs to judge whether a study is reasonably safe to start: the protocol, the investigator's brochure, chemistry, manufacturing and controls data, and nonclinical pharmacology and toxicology. Under 21 CFR 312.40, the IND takes effect 30 days after receipt, or sooner if FDA says so, and no investigator may dose a participant before then. FDA does not issue an approval letter in the usual case.

Silence after 30 days means the study may proceed, although ethics review by an IRB is also required before enrollment. If FDA finds a problem, it places a clinical hold under 21 CFR 312.42, which stops the study until the deficiencies are fixed. After the IND is active, the sponsor keeps it current with protocol amendments, safety reports and annual reports.

The EU works differently: there is no 30 day default, and each Member State issues an explicit decision through CTIS under the Clinical Trials Regulation. A common interview slip is to call the IND an approval to market. It covers only investigational use.

A strong answer covers

  • Purpose: permission for investigational use in humans
  • Core content: protocol, brochure, CMC and nonclinical data
  • Effective after 30 days unless on clinical hold
  • IRB approval still required
  • Contrast with explicit EU authorization through CTIS

Common mistakes

  • Believing FDA sends an approval letter before every IND study can start.
  • Forgetting that ethics committee approval is separate from the IND.
  • Treating an active IND as permission to market or promote the drug.