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21 CFR 50.50

§ 50.50 IRB duties.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 50.50, § 50.50 IRB duties, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83457
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In addition to other responsibilities assigned to IRBs under this part and part 56 of this chapter, each IRB must review clinical investigations involving children as subjects covered by this subpart D and approve only those clinical investigations that satisfy the criteria described in § 50.51, § 50.52, or § 50.53 and the conditions of all other applicable sections of this subpart D.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.