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US Food and Drug Administration regulatory approaches for xenotransplantation products and xenografts

US Food and Drug Administration regulatory approaches for xenotransplantation products and... 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. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Xenotransplantation Wiley

US Food and Drug Administration regulatory approaches for xenotransplantation products and xenografts

Xenotransplantation , Volume 27 (6) – Nov 1, 2020

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Publisher
Wiley
Copyright
© 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
ISSN
0908-665X
eISSN
1399-3089
DOI
10.1111/xen.12626
Publisher site
See Article on Publisher Site

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

XenotransplantationWiley

Published: Nov 1, 2020

Keywords: ; ; ;

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