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1.
Proc Natl Acad Sci U S A ; 118(22)2021 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-34050010

RESUMO

Technological advances, such as genome editing and specifically CRISPR, offer exciting promise for the creation of products that address public health concerns, such as disease transmission and a sustainable food supply and enable production of human therapeutics, such as organs and tissues for xenotransplantation or recombinant human proteins to treat disease. The Food and Drug Administration recognizes the need for such innovative solutions and plays a key role in bringing safe and effective animal biotechnology products to the marketplace. In this article, we (the Food and Drug Administration/Center for Veterinary Medicine) describe the current state of the science, including advances in technology as well as scientific limitations and considerations for how researchers and commercial developers working to create intentional genomic alterations in animals can work within these limitations. We also describe our risk-based approach and how it strikes a balance between our regulatory responsibilities and the need to get innovative products to market efficiently. We continue to seek input from our stakeholders and hope to use this feedback to improve the transparency, predictability, and efficiency of our process. We think that working together, using appropriate science- and risk-based oversight, is the foundation to a successful path forward.


Assuntos
Animais Geneticamente Modificados , Pesquisa Biomédica , Sistemas CRISPR-Cas , Edição de Genes , Animais , Humanos , Estados Unidos , United States Food and Drug Administration
2.
Nat Biotechnol ; 38(4): 503, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32139895

RESUMO

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

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