21 CFR 312.34
21 CFR 312.34 is the regulation in 21 CFR Part 312, Investigational New Drug Application. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 312.3, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 02025
- 12026
The regulation
The text of this section is not in the saved copy.
Text from eCFR.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 312.34.
- 21 CFR 312.3Definitions and interpretations1 letter cites both
- 21 CFR 312.60General responsibilities of investigators1 letter cites both
- 21 CFR 320.31Applicability of requirements regarding an “Investigational New Drug Application.”1 letter cites both
- 21 CFR 50.20General requirements for informed consent1 letter cites both
- 21 CFR 50.22Exception from informed consent requirements for minimal risk clinical investigations1 letter cites both
- 21 CFR 50.25Elements of informed consent1 letter cites both
- 21 CFR 50.3Definitions1 letter cites both
- 21 CFR 50.331 letter cites both
Latest letters citing it
The letter citing 21 CFR 312.34 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.