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Home / Library / Regulations and Guidelines / FDA 21 CFR 50: Protection of Human Subjects

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FDA Guidance

FDA 21 CFR 50: Protection of Human Subjects

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21 CFR 50 applies to 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

SKU: 300032 Category: Regulations and Guidelines

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