美國食藥署提出新指引草案,欲將改造動物基因視同藥物列管

連結:美國食藥署欲將改造動物基因視同藥物列管

美國食藥署(U.S. Food and Drug Administration,FDA)於上周發布一項草案,宣稱要把被編輯的動物基因視為藥物列入管轄。這是自雷根時代頒布「生技規範整合架構」(Coordinated Framework for Regulation of Biotechnology)以來,政府對基因改造規範的最新一次聲明。

小編評:科技新報的好文,大家可以看看內文,了解一下美國現在想做什麼喔。

連結:Guidance for Industry Regulation of Intentionally Altered Genomic DNA in Animals Draft Guidance

FDA is issuing this draft revised Guidance for Industry to clarify its approach to the regulation of intentionally altered genomic DNA in animals. This guidance addresses animals whose genomes have been intentionally altered using modern molecular technologies, which may include random or targeted DNA sequence changes including nucleotide insertions, substitutions, or deletions, or other technologies that introduce specific changes to the genome of the animal. This guidance applies to the intentionally altered genomic DNA in both the founder animal in which the initial alteration event occurred and the entire subsequent lineage of animals that contains the genomic alteration.

小編評:附上草案連結,如果有閒,小編真想好好看看全文跟內容…

 

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