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21 CFR Part 312 · Investigational New Drug Application

§ 312.20 Requirement for an IND

Subpart B - Investigational New Drug Application (IND) Official text on eCFR Amendment history

(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.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 312.20

Form FDA 483 observations citing this section, fiscal years 2009–2025 (Bioresearch Monitoring).

  • Failure to submit an IND 23
  • Starting a study before IND is in effect 6
  • IND for emergency research 1

Warning letters citing § 312.20

20 FDA warning letters since 2017 cite this section ; the most recent:

FDA guidance that cites § 312.20

Amendment history

Federal Register documents that created or amended this section.