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FDA Guidance

FDA 21 CFR 56: Institutional Review Boards

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21 CFR 56 applies to the Investigational Review Boards (IRBs) that monitor clinical investigations regulated by the FDA, including drugs, medical devices,ᅠbiological products, dietary supplements, infant formulas, and food & color additives.ᅠ

Requirements regarding record content, management, and retention can be found throughout this document.

Issuing Body

FDA Regulations

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