PART 314
21 CFR Part 314 defines submission and approval requirements for NDAs and ANDAs in the United States.
Usage Examples
- PART 314 was included in the cross-functional regulatory decision log.
- Program teams used PART 314 to align regulatory, quality, and clinical milestones.
- PART 314 improved consistency across global submission planning documents.
What is PART 314?
Part 314 describes application content, filing, amendments, postmarketing reporting, and approval standards for human drugs. Teams use it to map dossier content, patent and exclusivity strategy, and lifecycle submissions.
Regulatory Context
This term appears most often in general workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 314.
When This Matters
- PART 314 was included in the cross-functional regulatory decision log.
- Program teams used PART 314 to align regulatory, quality, and clinical milestones.
- PART 314 improved consistency across global submission planning documents.
Common Mistakes
- Relying on generic terminology without mapping to the active jurisdiction context.
- Skipping cross-links between terms, tools, and active regulatory references.
- Failing to maintain a single source of truth for regulatory definitions internally.
Related Regulations
Frequently Asked Questions
PART 314 is a regulatory concept used to improve submission quality, compliance consistency, and decision traceability.
PART 314 improves consistency in decisions, documentation, and authority communication.
Weak execution of PART 314 often leads to avoidable deficiencies, rework, and slower authority review cycles.
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Sources & References
