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The United States Food and Drug Administration's (FDA) regulatory approach for xenotransplantation products and xenografts encompasses regulatory considerations for biological products, medical devices, drugs, combination products, and genetically altered animals,… Click to show full abstract
The United States Food and Drug Administration's (FDA) regulatory approach for xenotransplantation products and xenografts encompasses regulatory considerations for biological products, medical devices, drugs, combination products, and genetically altered animals, depending on the product. This communication aims to clarify the regulatory approaches and considerations for animal‐derived products, specifically xenotransplantation and xenograft products.
Journal Title: Xenotransplantation
Year Published: 2020
Link to full text (if available)
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