There Is No FDA IND Database: What You Can Actually Look Up, and How the Form-1571 IND Clock Really Works

At a glance

• There is no public, searchable “FDA IND database” and no “IND approval list.” Under 21 CFR 312.130, FDA will not even disclose that an IND exists unless it has already been publicly acknowledged.
• What you can actually search are two different FDA web resources: BMIS (people and entities named on Forms 1571/1572, received since October 2008) and the IND Activity Reports (aggregate counts, not individual applications). They answer different questions.
• “IND approval” is a myth. An IND goes into effect by default 30 days after FDA receives it, unless FDA places it on clinical hold. Silence is the go signal, not a sign-off letter.
• The real job is an assembly-and-clock task, anchored to Form FDA-1571 (the cover sheet and table of contents that organize the whole submission).
• Three forms do three different jobs: 1571 (the IND cover sheet), 1572 (the investigator’s signed commitment), and 3674 (the ClinicalTrials.gov certification).
• This is a compliance explainer, not legal advice. Software and templates can help you assemble and track an IND, but the sponsor stays responsible for what is in it.

If you searched for an “FDA IND database,” you were probably expecting something like ClinicalTrials.gov: a public registry where you type a drug or a company and pull up the application. That database does not exist, and it does not exist for a specific, deliberate regulatory reason. This guide does two things: it dismantles the false premise (and points you to what is actually searchable), then it reframes your real task as assembling a Form-1571-anchored submission and understanding the 30-day clock that follows.

”FDA IND database”: why it does not exist

The reason there is no public IND registry is confidentiality, written directly into the regulation. 21 CFR 312.130(a) provides that the existence of an investigational new drug application will not be disclosed by FDA unless it has previously been publicly disclosed or acknowledged. Read that carefully: FDA will not even confirm that an IND exists for a given drug or sponsor unless the sponsor (or some other public act) has already put it on the record. The data and information inside the IND are handled under the same confidentiality framework that governs marketing applications.

So when you cannot find an “IND lookup” or an “IND approval list,” that is not your research failing. It is the regulation working as designed. Anyone selling you a public IND search tool is either describing one of the two resources below or describing something that is not what you think it is. There is no list of “approved INDs” to browse, partly because, as the next section explains, INDs are not “approved” in the first place.

What you CAN look up: BMIS vs. IND Activity Reports

Two real FDA web resources get conflated with the mythical IND database. They are not the same, and neither one lets you read someone else’s application. Their statutory backdrop is 21 CFR Part 312, which is why we cite it here even though the web pages themselves are FDA resources rather than a separate regulation.

	BMIS (Bioresearch Monitoring Information System)	IND Activity Reports
What it is	A searchable index of people and entities named on submitted forms	Aggregate statistics published by FDA
Who or what is in it	Clinical investigators, sponsor-investigators, CROs, and IRBs named on Forms FDA-1571 and 1572	Counts of IND activity (for example, new commercial vs. research INDs) over time
Granularity	Individual names and roles	Totals and trends, no individual applications
Coverage limit	Only forms received since October 2008	Period-level aggregates
What it will NOT tell you	The contents of any IND; whether a specific drug “passed”	Anything about a named sponsor’s specific application

The practical takeaway: BMIS answers “is this investigator or CRO already on record with FDA, and on what kinds of studies?” It is useful for vetting an investigator’s track record or confirming a site relationship. It does not let you read the protocol, the CMC section, or the safety data. The IND Activity Reports answer “how much IND activity is happening overall?” They are a landscape tool, not a lookup. Neither is a back door into a confidential application, because 312.130 closes that door.

The approval myth: “effective,” not “approved,” and the 30-day clock

This is the single most common and most consequential error in the popular write-ups, so it is worth being precise. INDs are not approved. They go into effect.

21 CFR 312.40(b) sets out exactly how: 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, or on earlier notification by FDA that the clinical investigations may begin. In other words, the default outcome of the 30-day window is that you may proceed. There is no approval letter to wait for. Silence at day 30 is the go signal.

Two corollaries follow directly from the text. First, 21 CFR 312.20(b) provides that a sponsor shall not begin a clinical investigation until the investigation is subject to an IND that is in effect under 312.40. You cannot dose a subject before the clock has run (or before earlier FDA notification). Second, the thing that actually stops you is a clinical hold. Under 21 CFR 312.42, a clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing one, and when a proposed study is placed on clinical hold, subjects may not be given the investigational drug. So the mental model is: you are clear to proceed at day 30 unless FDA affirmatively holds you. “No news” genuinely does mean “go,” which is the opposite of how most regulated submissions work, and exactly why teams misread it.

If you take one thing from this section, take this: never tell a colleague the IND was “approved.” Say it went into effect, or that no clinical hold was issued. The distinction is not pedantry. It changes what you are waiting for and what would stop you.

The initial IND, anchored to Form FDA-1571

Once you accept that there is nothing to look up and nothing to be approved, the work becomes assembly. 21 CFR 312.23 lays out the required content and the order of an initial IND, and the document that anchors and organizes it is the Form FDA-1571 cover sheet. Use the form’s structure as your checklist.

Form-1571 section (per 312.23)	What it contains	Statutory anchor
Cover sheet (Form FDA-1571)	Sponsor name and contact, drug name, phase(s), and the sponsor’s commitments	21 CFR 312.23(a)(1)
Commitment not to begin until in effect	Explicit commitment not to start clinical investigations until the IND is in effect	21 CFR 312.23(a)(1)(iii)
IRB commitment	Commitment that an IRB complying with Part 56 will conduct initial and continuing review	21 CFR 312.23(a)(1)(iv)
Monitoring and safety-review named persons	Person responsible for monitoring, and the person(s) responsible under 312.32 for safety review	21 CFR 312.23(a)(1)(vi)-(vii)
Table of contents	Required, to make the submission reviewable	21 CFR 312.23(a)(2)
Introductory statement and general investigational plan	Drug identity, prior human experience, and the plan for the coming year	21 CFR 312.23(a)(3)
Investigator’s brochure	If required under 312.55, summarizing pharmacology and toxicology	21 CFR 312.23(a)(5)
Protocol(s)	The specific human study protocol(s), the central focus of the initial submission	21 CFR 312.23(c)

A few notes on using this table. 312.23(c) states that the central focus of the initial IND submission should be the general investigational plan and the protocols, so do not let the CMC and pharm/tox sections crowd out a clear, well-built protocol. This guide deliberately does not go deep on CMC chemistry or full preclinical toxicology study design; those are large topics in their own right and you should follow FDA’s drug-specific guidance for them. The point here is the spine: the 1571 and its required order are what make the package a reviewable IND rather than a pile of documents.

The three forms: 1571, 1572, and 3674

These are routinely confused, and each certifies something different.

• Form FDA-1571 is the IND cover sheet and table of contents. It is the sponsor’s submission anchor and carries the sponsor’s commitments, including the commitment, under 21 CFR 312.23(a)(1)(iii), not to begin clinical investigations until the IND is in effect.
• Form FDA-1572 is the investigator’s signed statement. Under 21 CFR 312.53(c), before permitting an investigator to begin, the sponsor must obtain a signed Form FDA-1572 containing the investigator’s name and address, the protocol(s), the research facilities, the IRB responsible for review, and the investigator’s commitments to conduct the study per protocol and meet informed-consent and IRB requirements. The 1572 is where the investigator personally takes on those obligations.
• Form FDA-3674 is the ClinicalTrials.gov certification, confirming that any applicable clinical-trial registration requirements have been addressed. It is its own certification, separate from the 1571 and the 1572.

A clean way to remember it: 1571 is the sponsor’s cover and promises, 1572 is the investigator’s promises, and 3674 is the registration check. They are not interchangeable, and a complete submission generally needs all three in their respective roles.

Where ICH E6(R3) and BIMO fit, and one tension to flag

21 CFR Part 312 is the US statutory machinery for the IND. Two other in-scope sources shape how the people behind that submission are held to account.

ICH E6(R3) Good Clinical Practice assigns the underlying duties. ICH E6(R3) §3.7.1 makes the sponsor responsible for selecting the investigator(s)/institution(s) and requires that each investigator be qualified by education, training and experience with adequate resources. ICH E6(R3) §2.1.1 puts the same qualification requirement on the investigator. Crucially, ICH E6(R3) §3.6.6 provides that even when a sponsor transfers trial-related activities to a service provider, the ultimate responsibility for those activities, including participant safety and data reliability, resides with the sponsor. And ICH E6(R3) §3.15.1 requires the sponsor to ensure that an Investigator’s Brochure is developed and kept current, which is the same document the IND content rules expect under 312.23(a)(5). These align cleanly with Part 312’s allocation of duties.

The FDA Compliance Program 7348.811 (Bioresearch Monitoring) is the enforcement backstop. Under 7348.811, FDA conducts inspections of clinical investigators and sponsor-investigators to determine whether clinical studies are conducted in compliance with applicable statutory and regulatory requirements and to assure the quality and reliability of the data submitted to FDA. The program also makes clear that a sponsor-investigator, the individual who both initiates and conducts the investigation, must comply with the regulatory requirements applicable to both sponsors and clinical investigators. If you are an academic sponsor-investigator who assumed you only carry investigator duties, that is the line to underline.

One alignment worth stating plainly, because it is sometimes read as a conflict: Part 312 frames investigator selection as a sponsor obligation (21 CFR 312.53(a) requires the sponsor to select only qualified investigators), while ICH E6(R3) §2.1.1 simultaneously requires the investigator to be qualified and to provide evidence of it. These are not contradictory; they place a qualification duty on both parties at once. The sponsor must vet, and the investigator must be vettable and must document it. Treat them as two locks on the same door, not as competing demands.

Where teams get it wrong

• Treating ClinicalTrials.gov as an IND registry. It is a trial registry, not an IND database. It will never show you the confidential application, and confusing the two leads people to think their study is “findable” by regulators in ways it is not.
• Saying the IND was “approved.” It was not. It went into effect under 21 CFR 312.40(b), or earlier FDA notification let you proceed. The only thing that affirmatively stops you is a clinical hold under 312.42.
• Starting too early. 21 CFR 312.20(b) bars beginning the investigation until the IND is in effect. The 30-day clock is not advisory.
• Assuming BMIS shows everything. It only covers forms received since October 2008, and only the people and entities on them, never the application contents.
• Sponsor-investigators wearing one hat. Per FDA 7348.811, you carry both sponsor and investigator obligations, and BIMO inspections can examine both.

Where the real examples and guidance live

Because there is no IND to browse, your reference material is FDA’s own guidance and the form instructions. FDA publishes guidance documents on IND content and format and on the sponsor-investigator pathway, and the instructions accompanying Forms FDA-1571, 1572, and 3674 tell you what each field certifies. Read those alongside 21 CFR Part 312 itself, which is the authoritative text behind every checklist you will find online. When a third-party “IND example” conflicts with the regulation, the regulation wins.

For adjacent depth, see our companion pieces on investigator obligations and the Form 1572, on IND safety reporting under 312.32, and on the clinical-hold process, which expand the points this guide only touches.

Sources

• 21 CFR Part 312 — Investigational New Drug Application (version 2026-04, FDA)
• FDA Compliance Program 7348.811 — Bioresearch Monitoring: Clinical Investigators and Sponsor-Investigators (version 2020, FDA) — https://www.fda.gov/media/75927/download
• ICH E6(R3) Good Clinical Practice (version r3, ICH) — https://www.ich.org/page/efficacy-guidelines