---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chI/subchD/part314"
level: "part"
label: "Part 314"
heading: "Applications for Fda Approval to Market a New Drug"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chI-subchD-part314"
sections_count: 69
---

# Part 314 — Applications for Fda Approval to Market a New Drug

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-part314-subpartA.md)
- [Subpart B — Applications](/cfr/21/chI-subchD-part314-subpartB.md)
- [Subpart C — Abbreviated Applications](/cfr/21/chI-subchD-part314-subpartC.md)
- [Subpart D — FDA Action on Applications and Abbreviated Applications](/cfr/21/chI-subchD-part314-subpartD.md)
- [Subpart E — Hearing Procedures for New Drugs](/cfr/21/chI-subchD-part314-subpartE.md)
- [Subpart F — Subpart F [Reserved]](/cfr/21/chI-subchD-part314-subpartF.md)
- [Subpart G — Miscellaneous Provisions](/cfr/21/chI-subchD-part314-subpartG.md)
- [Subpart H — Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses](/cfr/21/chI-subchD-part314-subpartH.md)
- [Subpart I — Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible](/cfr/21/chI-subchD-part314-subpartI.md)