1.1 — Table of Contents
Complete table of contents for the submission
Requirements by Phase
Complete table of contents for the submission
Requirements by Phase
IND Phase 1: required IND Phase 2: required IND Phase 3: required NDA: required
Content Requirements
- Complete table of contents listing all documents in submission
- Paginated index with document titles and page numbers
- Cross-references to all modules and sub-sections
Expected Deliverables
- Table of contents document
- Paginated index
ICH Guidelines: 21 CFR 312.23(a)(2)
Source: 21 CFR 312.23(a)(2)
References
Sections
Related Sections
Up toModule 1: Administrative Information and Prescribing InformationCover letter identifying the IND submission type, serial number, and key information
Administrative information including contact details, certifications, and financial disclosures
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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