1.2.2 — Form FDA 1571 (IND)

FDA Form 1571 IND application cover form

Requirements by Phase

IND Phase 1: required IND Phase 2: required IND Phase 3: required

Content Requirements

• Sponsor name and address
• Drug name (established and proprietary)
• IND number (if previously assigned)
• Submission type (initial, amendment, protocol amendment, information amendment, IND safety report, annual report, response to clinical hold)
• Phase of clinical investigation
• Proposed indication(s)
• Serial number
• Contents listing of all components included
• Sponsor signature and date
• Identification of contract research organization (if applicable)
• Identification of any previously submitted related INDs

Expected Deliverables

• Completed signed FDA Form 1571

ICH Guidelines: 21 CFR 312.23(a)(1)

Note: IND-only form

Source: 21 CFR 312.23(a)(1)