21 CFR 812.42
§ 812.42 FDA and IRB approval.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 812.42, § 812.42 FDA and IRB approval, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88828
- Permanent ID
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Full text
A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both approved the application or supplemental application relating to the investigation or part of an investigation.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.