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US Food and Drug Administration regulatory approaches for xenotransplantation products and xenografts
Author(s) -
Arcidiacono Judith
Publication year - 2020
Publication title -
xenotransplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.052
H-Index - 61
eISSN - 1399-3089
pISSN - 0908-665X
DOI - 10.1111/xen.12626
Subject(s) - xenotransplantation , food and drug administration , drug , medicine , pharmacology , drug administration , transplantation , microbiology and biotechnology , biology
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.