---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chI/subchD/part312"
level: "part"
label: "Part 312"
heading: "Investigational New Drug Application"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chI-subchD-part312"
sections_count: 60
---

# Part 312 — Investigational New Drug Application

Title 21 C.F.R. — Food and Drugs › Chapter I — Food and Drug Administration, Department of Health and Human Services › Subchapter D — Drugs for Human Use

## Contents

- [Subpart A — General Provisions](/cfr/21/chI-subchD-part312-subpartA.md)
- [Subpart B — Investigational New Drug Application (IND)](/cfr/21/chI-subchD-part312-subpartB.md)
- [Subpart C — Administrative Actions](/cfr/21/chI-subchD-part312-subpartC.md)
- [Subpart D — Responsibilities of Sponsors and Investigators](/cfr/21/chI-subchD-part312-subpartD.md)
- [Subpart E — Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses](/cfr/21/chI-subchD-part312-subpartE.md)
- [Subpart F — Miscellaneous](/cfr/21/chI-subchD-part312-subpartF.md)
- [Subpart G — Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests](/cfr/21/chI-subchD-part312-subpartG.md)
- [Subpart H — Subpart H [Reserved]](/cfr/21/chI-subchD-part312-subpartH.md)
- [Subpart I — Expanded Access to Investigational Drugs for Treatment Use](/cfr/21/chI-subchD-part312-subpartI.md)