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Does a clinical investigation involving a marketed product require IRB review and approval?

April 26, 2017Approval clinical investigation involving IRB marketed Product require review

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Does a clinical investigation involving a marketed product require IRB review and approval?

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Yes, if the investigation is governed by FDA regulations [see 21 CFR 56.101, 56.102(c), 312.2(b)(1), 361.1, 601.2, and 812.2]. Also, see the information sheet entitled ” ‘Off-label’ and Investigational Use of Marketed Drugs and Biologics” for more information.