Tip for FDA Form 1571

The IND sponsor is legally responsible for the conduct of the clinical trial

Tip for FDA Form 1571

Pre-IND meetings with the FDA are highly recommended to discuss study design, endpoints, and regulatory strategy

Tip for FDA Form 1571

Electronic Common Technical Document (eCTD) format is required for most submissions

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Investigational New Drug Application (IND)

FDA Form 1571 · U.S. FDA

Traditional IND application form for expanded access submissions. Form 3926 is the simplified alternative for individual patients.

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Where to Submit This Form

🌐

Submit electronically through the FDA Electronic Submission Gateway (ESG)

https://www.fda.gov/industry/electronic-submissions-gateway

Electronic submission is strongly encouraged and increasingly required.

📬

Mail to the appropriate FDA review division

Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901-B Ammendale Road Beltsville, MD 20705-1266

Filing Deadline

An IND must be submitted at least 30 days before the proposed clinical trial begins. The FDA has 30 days to review and either allow or place a clinical hold.

Required Attachments

📎 Completed FDA Form 1571 (IND Application cover sheet)
📎 FDA Form 1572 (signed by each clinical investigator)
📎 Investigator's Brochure
📎 Clinical protocol(s)
📎 Chemistry, Manufacturing, and Controls (CMC) data
📎 Pharmacology and toxicology data (preclinical studies)
📎 Previous human experience with the drug (if any)

Processing Time

The FDA has 30 calendar days to review the IND. If the 30-day period expires without a clinical hold, the trial may proceed.

What Happens Next

If no clinical hold is issued within 30 days, the clinical trial may proceed. Annual reports must be submitted, and all serious adverse events must be reported promptly. Protocol amendments require prior FDA review.

Tips for This Form

✓ The IND sponsor is legally responsible for the conduct of the clinical trial
✓ Pre-IND meetings with the FDA are highly recommended to discuss study design, endpoints, and regulatory strategy
✓ Electronic Common Technical Document (eCTD) format is required for most submissions
✓ IND safety reports for serious and unexpected adverse reactions must be submitted within 15 days (7 days for fatal/life-threatening events)

More Clinical Trials Forms

Informed Consent Document (ICF)

Study-specific · Study sponsor / institution

Comprehensive document explaining the clinical trial: purpose, procedures, risks, benefits, alternatives, voluntariness, and right to withdraw. Must be approved by IRB.

HIPAA Authorization for Research

Institution-specific · Research institution

Separate authorization for use and disclosure of PHI for research purposes. May be broader than clinical HIPAA authorization.

Eligibility Screening / Inclusion-Exclusion Checklist

Study-specific · Study sponsor

Checklist confirming the participant meets all inclusion criteria and no exclusion criteria for the clinical trial.

Individual Patient Expanded Access IND Application

FDA Form 3926 · U.S. Food and Drug Administration

Simplified form for requesting compassionate use of investigational drugs for patients with serious or life-threatening conditions and no alternatives. FDA approves over 99% of requests. Requires manufacturer agreement to provide the drug.

Statement of Investigator

FDA Form 1572 · U.S. FDA

Statement of investigator qualifications and commitment to conduct the study per FDA regulations. Accompanies IND submissions.

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