Usage Examples
- The sponsor submitted the IND on 3 March, so the 30-day clock runs from FDA receipt, not from our internal sign-off.
- FDA placed the IND on clinical hold under 312.42, so no new subjects can be enrolled until the deficiency is resolved.
- The IND annual report is due within 60 days of the anniversary of the effective date, not the submission date.
What is IND (Investigational New Drug)?
IND is the FDA application a sponsor submits before shipping or administering an unapproved drug to human subjects, authorizing a clinical investigation rather than granting marketing approval. Studies of a lawfully marketed drug may be exempt.
IND exists because a drug with no approved marketing application cannot lawfully be put into people until FDA has seen the plan and the evidence behind it. 21 CFR Part 312 applies to all clinical investigations of products subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act, and the IND is how a sponsor enters that framework.
IND scope reaches any clinical investigation of such a product, but two boundaries matter more than sponsors expect. IND requirements do not touch a drug intended solely for tests in vitro or in laboratory research animals when it is shipped under § 312.160. A clinical investigation of a drug lawfully marketed in the United States is exempt when it is not intended to be reported to FDA as a well-controlled study supporting a new indication and does not involve a factor that significantly increases risk.
IND practice revolves around the effective date. An IND goes into effect 30 days after FDA receives it, unless FDA notifies the sponsor of a clinical hold, or earlier if FDA notifies the sponsor that the investigations may begin. From that date the IND becomes a live file rather than a one-time filing: expedited safety reports on 7-day and 15-day calendar clocks, and an annual progress report tied to the effective-date anniversary.
Not to be confused with
- NDA
- an NDA asks FDA to approve a drug for marketing; an IND asks only for permission to study it in humans. An IND going into effect confers no marketing authorization of any kind.
- Clinical hold
- a clinical hold is an FDA order to delay a proposed investigation or suspend an ongoing one under an existing IND. A hold stops the studies; it does not withdraw or invalidate the IND itself.
- IRB approval
- an IRB reviews and approves the study under Parts 50 and 56; the IND is the sponsor's filing with FDA. 21 CFR 312.40(a) requires both, and neither one substitutes for the other.
- Phase 1
- Phase 1 names a stage of the investigation, not the regulatory filing that authorizes it. FDA's clinical-hold grounds are written phase-specifically, so a hold on a Phase 1 study is assessed against different criteria than a later-phase study.
The IND obligations that bind a sponsor sit in Part 312 and start before the first dose.
What you must do
- 1Submit an IND to FDA and let it go into effect before any investigator administers the investigational drug to a human subject21 CFR 312.40(a)
- 2Count the effective date as 30 days from FDA's receipt of the IND, unless FDA imposes a clinical hold or notifies the sponsor earlier that the clinical investigations may begin21 CFR 312.40(b)
- 3Ensure the sponsor and each participating investigator meet the informed-consent and institutional-review-board requirements of Parts 50 and 56 alongside the IND itself21 CFR 312.40(a)
- 4Notify FDA of any unexpected fatal or life-threatening suspected adverse reaction no later than 7 calendar days after the sponsor's initial receipt of the information, and report other potential serious risks no later than 15 calendar days after the sponsor determines the information qualifies21 CFR 312.32(c)
- 5Submit a brief report of the progress of the investigation within 60 days of the anniversary date the IND went into effect21 CFR 312.33
- 6Confirm no exemption applies before filing, since in vitro and laboratory-research-animal use and qualifying studies of a lawfully marketed drug sit outside Part 31221 CFR 312.2(b)
Common mistakes
Counting the 30 days from the sponsor's submission date rather than FDA's receipt
21 CFR 312.40(b)(1) starts the clock when FDA receives the IND. Teams that plan a first-dose date off their own send date can dose before the IND is in effect, which 312.40 prohibits outright and which converts a scheduling error into an unauthorized clinical investigation.
Assuming a marketed-drug study is automatically exempt
the 312.2(b) exemption is conditional, not categorical. Change the route of administration, the dose level, or the patient population in a way that significantly increases risk, or intend the study as a well-controlled study supporting a new indication, and the exemption falls away. The study then needed an IND from the first subject, retroactively.
Running both safety clocks off the same trigger
21 CFR 312.32(c) starts the 7-day clock at the sponsor's initial receipt of information about an unexpected fatal or life-threatening suspected adverse reaction, but starts the 15-day clock when the sponsor determines the information qualifies for reporting. A pharmacovigilance process that waits for causality assessment before starting any clock will be late on exactly the cases FDA cares about most.
When This Matters
- The sponsor submitted the IND on 3 March, so the 30-day clock runs from FDA receipt, not from our internal sign-off.
- FDA placed the IND on clinical hold under 312.42, so no new subjects can be enrolled until the deficiency is resolved.
- The IND annual report is due within 60 days of the anniversary of the effective date, not the submission date.
Frequently Asked Questions
An IND goes into effect 30 days after FDA receives it, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold. FDA can also authorize an earlier start by notifying the sponsor that the clinical investigations may begin. Before that date, no investigator may administer the drug to a human subject.
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