Submission & Approval

Investigational New Drug(IND)

An application to the FDA to begin clinical trials of a new drug in humans.

Usage Examples

The sponsor submitted an IND to initiate Phase 1 clinical trials.
FDA placed the IND on clinical hold pending additional safety data.
The IND annual report was submitted on the anniversary date.

What is IND?

An Investigational New Drug (IND) application is required before a sponsor can begin clinical trials of a new drug in the United States. The IND provides FDA with information about the drug's composition, manufacturing, preclinical data, and proposed clinical study protocols.

There are three types of INDs: Commercial INDs for drugs intended for marketing, Research INDs for scientific study without commercial intent, and Emergency INDs for life-threatening situations. INDs automatically become effective 30 days after FDA receipt unless FDA places the study on clinical hold.

The IND process ensures that clinical trial participants are not exposed to unreasonable risks while allowing promising drugs to be evaluated in humans.

Regulatory Context

This term appears most often in submission & approval workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 312, 21 CFR 50, 21 CFR 56.

FDAICHEMA

When This Matters

The sponsor submitted an IND to initiate Phase 1 clinical trials.
FDA placed the IND on clinical hold pending additional safety data.
The IND annual report was submitted on the anniversary date.

Common Mistakes

Treating submission readiness as a formatting-only check without lifecycle validation.
Using outdated guidance references across modules and summaries.
Missing cross-functional review between RA, CMC, and quality before submission.

Related Regulations

21 CFR 31221 CFR 5021 CFR 56

Frequently Asked Questions

An IND becomes effective 30 days after FDA receives it, unless FDA notifies the sponsor of a clinical hold or requests additional information.

A pre-IND meeting is an optional meeting with FDA to discuss development plans, proposed studies, and IND content before submission, helping to identify potential issues early.

FDA may place an IND on clinical hold if subjects would be exposed to unreasonable risk, the IND lacks sufficient information, investigators are unqualified, or the investigator brochure is misleading.