21 CFR 312.40
General requirements for use of an investigational new drug in a clinical investigation
21 CFR 312.40 is the regulation titled “General requirements for use of an investigational new drug in a clinical investigation” in 21 CFR Part 312, Investigational New Drug Application. Since 2021, 10 FDA warning letters have cited it.
- Letters citing it
- 10 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 10 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.
The regulation
Read the text of 21 CFR 312.40 (eCFR, as of Sep 1, 2026)
(a) An investigational new drug may be used in a clinical investigation if the following conditions are met:
(1) The sponsor of the investigation submits an IND for the drug to FDA; the IND is in effect under paragraph (b) of this section; and the sponsor complies with all applicable requirements in this part and parts 50 and 56 with respect to the conduct of the clinical investigations; and
(2) Each participating investigator conducts his or her investigation in compliance with the requirements of this part and parts 50 and 56.
(b) An IND goes into effect:
(1) Thirty days after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold under § 312.42; or
(2) On earlier notification by FDA that the clinical investigations in the IND may begin. FDA will notify the sponsor in writing of the date it receives the IND.
(c) A sponsor may ship an investigational new drug to investigators named in the IND:
(1) Thirty days after FDA receives the IND; or
(2) On earlier FDA authorization to ship the drug.
(d) An investigator may not administer an investigational new drug to human subjects until the IND goes into effect under paragraph (b) of this section.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 312.40.
- 21 CFR 312.2Applicability10 letters cite both
- 21 CFR 312.20Requirement for an IND10 letters cite both
- 21 CFR 312.60General responsibilities of investigators2 letters cite both
- 21 CFR 50.20General requirements for informed consent2 letters cite both
- 21 CFR 50.23Exception from general requirements2 letters cite both
- 21 CFR 3.2Definitions1 letter cites both
- 21 CFR 312.21Phases of an investigation1 letter cites both
- 21 CFR 312.57Recordkeeping and record retention1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 312.40 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 Pamela K. Den Besten, DDS, MSLivionex Dental GelIssuedSep 19, 2025PostedSep 30, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.