21 CFR § 812.62
IRB approval
June 25, 2020
(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all investigations covered by this part.
(b) If no IRB exists or if FDA finds that an IRB's review is inadequate, a sponsor may submit an application to FDA.
[46 FR 8957, Jan. 27, 1981]
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