Module 1administrativenda● Critical
1.2.1 — Application Form (FDA Form 356h)
FDA Form 356h application form for NDA/BLA submissions
Requirements by Phase
Phase 1
N/A
Phase 2
N/A
Phase 3
N/A
NDA
required
FDA Form 356h application form for NDA/BLA submissions
Requirements by Phase
NDA: required
Content Requirements
- Completed FDA Form 356h for NDA/BLA submissions
- Application type identification
- Applicant information
- Product information (name, dosage form, route, strength)
Expected Deliverables
- Completed FDA Form 356h
ICH Guidelines: 21 CFR 314.50
Note: IND uses Form 1571 instead
Source: 21 CFR 314.50
References
Related Sections
Up to1.2 — Cover Letter1.2.2 — Form FDA 1571 (IND)
FDA Form 1571 IND application cover form
1.2.3 — Form FDA 1572 (Statement of Investigator)
FDA Form 1572 signed statement from each participating investigator
1.2.4 — Form FDA 3674 (ClinicalTrials.gov)
FDA Form 3674 certification of compliance with ClinicalTrials.gov requirements
1.2.5 — Prescribing Information / Labeling
Prescribing information and approved labeling for NDA
1.2.6 — Patent Information
Patent information for Orange Book listing
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