---
kind: "section"
citation: "21 C.F.R. § 312.20"
title: "21"
number: "312.20"
heading: "Requirement for an IND."
url: "https://uscodex.org/cfr/21/312.20"
---

# §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)](/cfr/21/312.2.md?p=a).
- (b) A sponsor shall not begin a clinical investigation subject to [§ 312.2(a)](/cfr/21/312.2.md?p=a) until the investigation is subject to an IND which is in effect in accordance with [§ 312.40](/cfr/21/312.40.md).
- (c) A sponsor shall submit a separate IND for any clinical investigation involving an exception from informed consent under [§ 50.24](/cfr/21/50.24.md) 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.

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.

### Source

Source: 52 FR 8831, Mar. 19, 1987, unless otherwise noted.

### Amendments

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