Module 1administrativendaind● High priority
1.3.1 — Cover Letter
Cover letter identifying the submission type and key information
Requirements by Phase
Phase 1
required
Phase 2
required
Phase 3
required
NDA
required
Cover letter identifying the submission type and key information
Requirements by Phase
IND Phase 1: required IND Phase 2: required IND Phase 3: required NDA: required
Content Requirements
- Cover letter identifying submission type and key information
- Sponsor contact details for regulatory correspondence
- Summary of submission contents
Expected Deliverables
- Cover letter (PDF)
ICH Guidelines: 21 CFR 312.23(a)(1)
Source: 21 CFR 312.23(a)(1)
References
Related Sections
Up to1.3 — Administrative Information1.3.2 — Financial Disclosure
Financial disclosure forms (Form 3454/3455) for clinical investigators
1.3.3 — Debarment Certification
Debarment certification under Generic Drug Enforcement Act
1.3.4 — Environmental Assessment
Environmental assessment or categorical exclusion claim
1.3.5 — Patent and Exclusivity Information
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