1.3 — Administrative Information
Administrative information including contact details, certifications, and financial disclosures
Requirements by Phase
Administrative information including contact details, certifications, and financial disclosures
Requirements by Phase
IND Phase 1: required IND Phase 2: required IND Phase 3: required NDA: required
Content Requirements
- Sponsor and contact information
- Field copy certification
- Debarment certification
- Financial disclosure for clinical investigators
- Patent and exclusivity information
Expected Deliverables
- Administrative information package
ICH Guidelines: 21 CFR 312.23
Source: 21 CFR 312.23
References
Sections
Cover letter identifying the submission type and key information
Financial disclosure forms (Form 3454/3455) for clinical investigators
Debarment certification under Generic Drug Enforcement Act
Environmental assessment or categorical exclusion claim
Related Sections
Up toModule 1: Administrative Information and Prescribing InformationComplete table of contents for the submission
Cover letter identifying the IND submission type, serial number, and key information
Letters of authorization, right of reference statements, and cross-references to other applications
Application status requests including withdrawal, inactivation, and reactivation
Meeting requests and minutes for pre-IND, pre-NDA/BLA, and Type A/B/C meetings
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