21 CFR 312.20
§ 312.20 Requirement for an IND.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 312.20, § 312.20 Requirement for an IND, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86266
- Permanent ID
ys:prov:86266@1- SHA-256
3dfdc83064c91f6408414917a4bd21b13f7fb8246b229a6cc3b6e79d9df9b6a6
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.