1.10 — Labeling
Draft labeling and Investigator Brochure (labeling section)
Requirements by Phase
Draft labeling and Investigator Brochure (labeling section)
Requirements by Phase
IND Phase 1: optional IND Phase 2: optional IND Phase 3: optional NDA: required
Content Requirements
- Draft labeling for the drug product
- Investigator Brochure labeling section
- Carton and container labels
- Package insert draft (if applicable)
Expected Deliverables
- Draft labeling
- Investigator Brochure
ICH Guidelines: 21 CFR 201, 21 CFR 312.23(a)(5)
Source: 21 CFR 312.23(a)(5)
References
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
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
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