Investigational New Drug Application (IND)

Key facts

Regulation

21 CFR Part 312

Statutory basis

FD&C Act Section 505(i)

Forms

Form FDA 1571 cover sheet; Form FDA 1572 for each investigator

Waiting period

Trial may start 30 days after FDA receipt unless FDA imposes a hold

Reviewed by

FDA CDER or CBER, depending on the product

What is an Investigational New Drug Application?

Federal law generally prohibits shipping an unapproved drug across state lines. An IND, filed under Section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations at 21 CFR Part 312, provides the exemption that lets a sponsor ship an investigational drug or biologic to clinical investigators.

An IND is not an approval to market. It is permission to study, and it stays in effect as the drug moves through Phases 1, 2 and 3, with new protocols and safety information added as amendments. Medical devices use a different pathway, the Investigational Device Exemption (IDE).

What an IND contains and how review works

After FDA receives an initial IND, the sponsor must wait 30 days before starting the trial unless FDA notifies it sooner. During that window FDA reviews the submission for safety and can impose a clinical hold that delays or stops the study. An initial IND typically includes:

• Animal pharmacology and toxicology data showing the drug is reasonably safe for initial testing in humans.
• Manufacturing information on the composition, stability and controls of the drug substance and drug product.
• Clinical protocols and information on the qualifications of the investigators.
• An investigator brochure and commitments to obtain informed consent and Institutional Review Board (IRB) review.

Types of INDs

FDA groups INDs into commercial and research (noncommercial) categories, and describes several types by who files them and why:

• Investigator INDs: filed by a physician who both initiates and conducts a study, often in academic research.
• Emergency use INDs: allow use of an experimental drug in an emergency that does not allow time for a standard submission.
• Treatment INDs: allow wider use of a promising drug for serious or immediately life-threatening conditions while trials continue.
• Commercial INDs: filed by companies that intend to seek marketing approval.

Why the IND matters

An IND marks the formal start of clinical development, and the 30-day review and any clinical holds drive early timelines. FDA generally does not disclose the existence of an IND unless the sponsor has made it public, so analysts infer IND status from company disclosures and trial registrations.

Clinical hold announcements can move company valuations, and designations such as Fast Track and Breakthrough Therapy are requested while a drug is under an IND, so the IND frames most early regulatory milestones.