21 CFR § 312.20 - Requirement for an IND.

---
identifier: "/us/cfr/t21/s312.20"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 312.20 - Requirement for an IND."
title_number: 21
title_name: "Food and Drugs"
section_number: "312.20"
section_name: "Requirement for an IND."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "312"
part_name: "INVESTIGATIONAL NEW DRUG APPLICATION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262."
regulatory_source: "52 FR 8831, Mar. 19, 1987, unless otherwise noted."
cfr_part: "312"
---


# 312.20 Requirement for an IND.

(a) A sponsor shall submit an IND to FDA if the sponsor intends to conduct a clinical investigation with an investigational new drug that is subject to § 312.2(a).

(b) A sponsor shall not begin a clinical investigation subject to § 312.2(a) until the investigation is subject to an IND which is in effect in accordance with § 312.40.

(c) A sponsor shall submit a separate IND for any clinical investigation involving an exception from informed consent under § 50.24 of this chapter. Such a clinical investigation is not permitted to proceed without the prior written authorization from FDA. FDA shall provide a written determination 30 days after FDA receives the IND or earlier.

[52 FR 8831, Mar. 19, 1987, as amended at 61 FR 51529, Oct. 2, 1996; 62 FR 32479, June 16, 1997]