Module 1administrativenda
1.2.7 — Exclusivity Claims
Exclusivity claims (orphan, pediatric, NCE)
Requirements by Phase
Phase 1
N/A
Phase 2
N/A
Phase 3
N/A
NDA
required
Exclusivity claims (orphan, pediatric, NCE)
Requirements by Phase
NDA: required
Content Requirements
- Orphan drug exclusivity claims (if applicable)
- Pediatric exclusivity claims (if applicable)
- New chemical entity (NCE) exclusivity claims (5-year)
- New clinical investigation exclusivity claims (3-year)
- Supporting documentation for each exclusivity claim
Expected Deliverables
- Exclusivity request letter
- Supporting documentation
ICH Guidelines: 21 CFR 314.108
Source: 21 CFR 314.108
References
Related Sections
Up to1.2 — Cover Letter1.2.1 — Application Form (FDA Form 356h)
FDA Form 356h application form for NDA/BLA submissions
1.2.2 — 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
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