How to Fill Out and Submit Form FDA 1571 (IND Application)

FDA Form 1571 is the cover sheet for an Investigational New Drug (IND) application, and to fill it out you work through roughly 20 fields identifying the sponsor, the drug, the clinical phase, the type of submission, and an index of the supporting dossier that travels with it. The form is short. What makes it consequential is that it certifies the entire package underneath it and starts the 30-day clock during which the FDA decides whether your clinical trial can begin. This guide walks through how to fill out FDA Form 1571, what to attach, how to submit it, and what happens after it lands at the agency.

What Form 1571 Is and When You Need It

Any product intended to diagnose, treat, or prevent disease is a drug under federal law, and it cannot be shipped across state lines for human use without either an approved marketing application or an active IND.¹ The regulations at 21 CFR Part 312 spell out the prohibition and the way around it: file an IND, and Form 1571 is the front page of that filing.²

You need an IND whenever a clinical investigation of an unapproved drug involves human subjects. You also need one to study an already-approved drug at a significantly different dose, in a new patient population, or through a different route of administration, because the FDA treats those changes as opening a fresh safety question.

Not every study of a marketed drug requires an IND. Under 21 CFR 312.2(b)(1), a clinical investigation of a lawfully marketed drug is exempt when it is not intended to support a new indication or a significant labeling or advertising change, does not involve a route, dose, or population that significantly raises risk, complies with IRB and informed consent rules, and does not commercially promote the investigational drug.³ The FDA does not issue exemption letters for studies that clearly meet those criteria. If the fit is genuinely ambiguous, the agency directs sponsors to ask through the CDER NextGen portal rather than file a full IND.

Before You File: Consider a Pre-IND Meeting

You can request a formal pre-IND meeting before assembling the full package. These are Type B meetings, scheduled within 60 days of the FDA receiving the request, giving you up to 60 minutes of direct feedback on your development plan and clinical protocols.⁴ The meeting package, submitted at least 30 days before the scheduled date, typically runs 50 to 100 pages; the FDA will not commit to reviewing packages beyond 250 to 300 pages, and may cancel a meeting if the package is too thin to address the questions posed.

For first-time sponsors and investigator-initiated studies the investment pays off. Product quality issues are the most common reason the FDA puts a trial on hold, and a pre-IND meeting is where those issues surface early.

Filling Out Form 1571 Field by Field

Download the current version from the FDA’s IND Forms and Instructions page.⁵ Here is what each field asks for.⁶

Field 1, Select appropriate center. Drug products go to the Center for Drug Evaluation and Research (CDER); biological products typically go to the Center for Biologics Evaluation and Research (CBER).
Field 2, Name of sponsor. The person or organization that takes responsibility for and initiates the clinical investigation.
Field 3, Date of submission. The date you are submitting. This should match the date on your cover letter.
Fields 4 and 5, Sponsor address and telephone number. Full mailing address and contact phone.
Field 6, Name(s) of drug. Established name and trade name (if any), dosage form, and the Unique Ingredient Identifier (UNII) term and code for the active substance.
Field 7A, IND number. Leave blank on an initial submission. The FDA assigns the number, and you use it on every subsequent filing.
Field 7B, IND type. Commercial IND or Research IND. This choice affects your submission format requirements.
Field 8A, Proposed indication for use. The condition you intend to treat or diagnose. Note whether it qualifies as a rare disease (prevalence under 200,000 U.S. patients).
Field 8B, SNOMED CT disease term. The standardized coded disease term matching Field 8A.
Field 9, Phase(s) of investigation. Phase 1, Phase 2, Phase 3, or a combination.
Field 10, Cross reference. Previously submitted information supporting the application, such as a Drug Master File.
Field 11, Serial number. Number submissions consecutively. The initial IND is 0000.
Field 12A, Submission type. Check every box that applies: initial IND, protocol amendment, annual report, IND safety report, response to clinical hold, and so on.
Field 12B, Digital Health Technology data. Indicate whether the submission includes DHT data or a proposal to collect it.
Field 13, Combination products. Mark whether the product combines a drug with a device or biological product.
Field 14, Justification statement. If applicable, attach a justification statement with the application.
Field 15, Contents of application. A checklist of items 1 through 12 showing exactly which components are included. This is the index tying the cover sheet to the dossier.
Field 16, Contract research organizations. Whether a CRO will conduct any part of the study, and the names of the organizations.
Fields 17 and 18, Responsible persons. Name and title of the person monitoring the clinical investigations, and the person responsible for safety report review and evaluation.

The form closes with a certification that all information is true, accurate, and complete, signed electronically by the authorized representative. That certification is not a formality. Knowingly submitting false statements to a federal agency violates 18 U.S.C. § 1001 and can result in fines up to $250,000, up to five years in prison, or both.⁷⁸

What Field 15 Indexes: Your IND Dossier

Field 15 is the part of the form that ties directly to everything else you are submitting. Under 21 CFR 312.23, the dossier the form covers must include:

A table of contents following the order specified in the regulations.
An introductory statement and general investigational plan for the coming year.
The investigator’s brochure, compiling clinical and nonclinical data investigators need to understand the study rationale and risks.
Clinical protocols with objectives, patient selection criteria, dosing, safety monitoring procedures, and endpoints.
Chemistry, manufacturing, and controls (CMC) data showing how the drug is made, tested for purity and potency, and stored.
Pharmacology and toxicology data from animal studies and in vitro testing supporting the conclusion that the drug is reasonably safe for the proposed human study.
Previous human experience, whether domestic or foreign.

The depth of each section scales with the trial phase. A Phase 1 first-in-human study can rely on more limited manufacturing data and a shorter toxicology package than a Phase 3 trial enrolling thousands of patients. At every phase, the standard is whether the data lets the FDA assess whether participants face unreasonable risk.

Submitting the Form

There is no FDA user fee for filing an IND. The substantial user fees under the Prescription Drug User Fee Act apply to new drug applications and biologics license applications, not to INDs.⁹

Electronic Format

Since May 2018, all commercial IND applications and their amendments, supplements, and reports must be submitted in Electronic Common Technical Document (eCTD) format.¹⁰ Noncommercial INDs, including investigator-sponsored and expanded-access applications, are encouraged but not required to use eCTD. The FDA currently accepts eCTD v3.2.2 and began accepting eCTD v4.0 on September 16, 2024.

How to Transmit

The Electronic Submissions Gateway Next Generation (ESG NextGen) is the primary channel. It offers three options:¹¹

The Unified Submission Portal (USP), a web-based interface that replaced the legacy WebTrader. You upload your submission and track its status through center receipt.
API integration, for organizations automating the workflow between internal systems and the FDA gateway.
AS2 connection, a system-to-system automated channel for high-volume submitters.

If you need to submit physical electronic media, the mailing destination depends on the product. Drug products go to CDER’s Central Document Room at 5901-B Ammendale Road, Beltsville, MD 20705-1266. Biological products regulated by CBER go to the Document Control Center at 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002.

After You Submit: The 30-Day Clock

Once the FDA receives a complete IND, a 30-calendar-day clock starts. During that window you cannot administer the drug to any human subjects.¹² Reviewers use the time to work through toxicology, protocols, and manufacturing data and decide whether participants would face unreasonable risk.

Two outcomes are possible. If no clinical hold order comes within 30 days, the IND goes into effect automatically and you can begin shipping the drug and enrolling subjects.¹³ Sometimes the FDA notifies you before the 30 days expire that you are cleared to proceed early. The other outcome is a clinical hold, an FDA order pausing all or part of the investigation before it starts. Product quality issues — impurities, unqualified degradation products, gaps in manufacturing controls — are the most frequent trigger, and lifting a hold requires a written complete response addressing every issue in the FDA’s hold letter, after which the agency has 30 days to reply.¹⁴

Using Form 1571 After the IND Is Active

Getting the IND into effect does not retire Form 1571. Every amendment, report, or piece of correspondence you send the FDA for that IND must be accompanied by a new Form 1571 with the appropriate boxes checked in Field 12A. Two ongoing filings come up most.

Protocol amendments are required for changes significantly affecting subject safety, the scope of the investigation, or scientific quality — dose or exposure increases beyond the current protocol, major design changes, or added or removed safety monitoring. A change needed to eliminate an apparent immediate hazard to subjects can be implemented right away, provided you notify the FDA with a protocol amendment afterward.² Information amendments carry essential new data that does not fit within a protocol amendment, safety report, or annual report: new toxicology findings, updated chemistry data, a decision to discontinue a study.

Annual reports are due within 60 days of the anniversary date the IND went into effect.¹⁵ They summarize each study’s status and enrollment demographics, adverse experiences by body system, deaths and adverse-event dropouts, nonclinical progress, significant manufacturing changes, foreign marketing developments, and the plan for the coming year. Missing the 60-day window does not automatically terminate the IND, but chronic reporting noncompliance can give the FDA grounds to place the IND on hold or withdraw it.

One boundary worth noting: emergency use and treatment INDs follow streamlined procedural paths meant for life-threatening situations and expanded access, and requests can be initiated by phone or other rapid communication.¹⁶ The core obligation is the same. Form 1571 accompanies the submission, and the sponsor takes responsibility for how the drug is used throughout the investigation.

1
Office of the Law Revision Counsel. 21 U.S.C. 321 – Definitions; Generally
2
eCFR. 21 CFR Part 312 – Investigational New Drug Application
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U.S. Food and Drug Administration. IND Application Procedures: Exemptions From IND Requirements
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U.S. Food and Drug Administration. OTP Pre-IND Meetings
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U.S. Food and Drug Administration. IND Forms and Instructions
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U.S. Food and Drug Administration. Instructions for Filling Out Form FDA 1571
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Office of the Law Revision Counsel. 18 U.S. Code 1001 – Statements or Entries Generally
8
Office of the Law Revision Counsel. 18 U.S. Code 3571 – Sentence of Fine
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U.S. Food and Drug Administration. Prescription Drug User Fee Amendments
10
U.S. Food and Drug Administration. Electronic Common Technical Document (eCTD)
11
U.S. Food and Drug Administration. Electronic Submissions Gateway Next Generation (ESG NextGen)
12
Food and Drug Administration. Investigational New Drug (IND) Application
13
Food and Drug Administration. IND Application Procedures: Overview
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U.S. Food and Drug Administration. IND Application Procedures: Clinical Hold
15
eCFR. 21 CFR 312.33 – Annual Reports
16
Food and Drug Administration. Emergency Use of an Investigational Drug or Biologic