21 CFR 56.113
Suspension or termination of IRB approval of research
21 CFR 56.113 is the regulation titled “Suspension or termination of IRB approval of research” in 21 CFR Part 56, Institutional Review Boards. Since 2021, 2 FDA warning letters have cited it.
- Letters citing it
- 2 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 56.108, in 2 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.
- 02021
- 02022
- 02023
- 22024
- 02025
- 02026
The regulation
Read the text of 21 CFR 56.113 (eCFR, as of Sep 1, 2026)
An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the Food and Drug Administration.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 56.113.
Latest letters citing it
The 2 letters citing 21 CFR 56.113 that FDA posted most recently.
- DrugsView Louisiana State University Health Science Center IRBN/AIssuedSep 27, 2024PostedOct 8, 2024
- DrugsView New York State Psychiatric Institute IRBInstitutional Review Board (IRB) procedures for the protection of human subjectsIssuedMar 21, 2024PostedMar 26, 2024
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Counts include every citation in a letter, as the Letters filter does. How this database is built.