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The FDA has the authority to approve the following products: New human drugs Biological products such as therapeutic proteins, vaccines, allergenic products, cellular and gene therapies, and products manufactured from blood plasma Food additives intended for human consumption The FDA uses a risk-based, tiered approach for regulating medical devices for people The FDA also uses a risk-based approach for human cells and tissues The FDA is not responsible for approving the following products: Compounded drugs Tabacco products Cosmetics Medical foods Infant formula Dietary supplements The food label, including the nutrition facts label Structure-function claims on dietary supplements and other foods Compounded drugs New Human Drugs and Biological Products All new human drugs and biological products are required to undergo premarket FDA approval
That scale allows sponsors to plan for growth without sacrificing control
The focus is educational and research-use-only
161 ZaltieriM.LonghenaF.PizziM.MissaleC.SpanoP.BellucciA
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