21 CFR 312.20
Requirement for an IND
21 CFR 312.20 is the regulation titled “Requirement for an IND” in 21 CFR Part 312, Investigational New Drug Application. Since 2021, 18 FDA warning letters have cited it.
- Letters citing it
- 18 since 2021
- Jan 1 to Oct 30, 2026
- 2 against 3 on the same dates in 2025
- Most often cited with
- 21 CFR 312.2, in 18 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 312.20 most often, as written in the letters.
- 5 lettersYou failed to submit an Investigational New Drug application (IND) for the conduct of a clinical investigation with an investigational new drug that is subject to 21 CFR 312.2(a) [21 CFR 312.20(a), 312.20(b), and…
- 2 lettersFailure to submit INDs for the conduct of clinical investigations with investigational new drugs subject to 21 CFR 312.2(a) [21 CFR 312.20 and 312.40(a)]
- 2 lettersYou failed to submit an Investigational New Drug application (IND) for the conduct of a clinical investigation with investigational new drugs that is subject to 21 CFR 312.2(a) [21 CFR 312.20(a), 312.20(b), and…
The regulation
Read the text of 21 CFR 312.20 (eCFR, as of Sep 1, 2026)
(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]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 312.20.
- 21 CFR 312.2Applicability18 letters cite both
- 21 CFR 312.40General requirements for use of an investigational new drug in a clinical investigation10 letters cite both
- 21 CFR 312.3Definitions and interpretations4 letters cite both
- 21 CFR 312.7Promotion of investigational drugs4 letters cite both
- 21 CFR 312.60General responsibilities of investigators3 letters cite both
- 21 CFR 50.27Documentation of informed consent3 letters cite both
- 21 CFR 312.57Recordkeeping and record retention2 letters cite both
- 21 CFR 312.62Investigator recordkeeping and record retention2 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 312.20 that FDA posted most recently.
- DrugsView Center For Immunology Science, LLCheat-killed Mycobacteria smegmatisIssuedJan 13, 2026PostedJan 27, 2026
- DrugsView Prodrome Sciences USA, LLCProdromeNeuro™ OilIssuedJan 8, 2026PostedJan 20, 2026
- DrugsView Verdure Sciences, Inc.Maplifa®IssuedNov 10, 2025PostedNov 18, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.