Code of Federal Regulations · Section

§ 812.62 — Irb Approval

21 C.F.R. § 812.62

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(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.

21 C.F.R. § 812.60 21 C.F.R. § 812.64

Authorizing Statute