PART 312
21 CFR Part 312 governs Investigational New Drug applications and clinical study conduct for investigational drugs in the US.
Usage Examples
- Program teams used PART 312 to align regulatory, quality, and clinical milestones.
- PART 312 improved consistency across global submission planning documents.
- PART 312 was included in the cross-functional regulatory decision log.
What is PART 312?
Part 312 defines when an IND is required, what sponsors and investigators must submit, and how FDA can impose or release clinical holds. Clinical, regulatory, and safety teams rely on these rules to keep studies compliant from first-in-human through pivotal development.
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 312.
When This Matters
- Program teams used PART 312 to align regulatory, quality, and clinical milestones.
- PART 312 improved consistency across global submission planning documents.
- PART 312 was included in the cross-functional regulatory decision log.
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 312 is a regulatory concept used to improve submission quality, compliance consistency, and decision traceability.
PART 312 improves consistency in decisions, documentation, and authority communication.
Weak execution of PART 312 often leads to avoidable deficiencies, rework, and slower authority review cycles.
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Sources & References
