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The European Medicines Agency (EMA) is similar in this regard, although interestingly, that’s not the case in the United Kingdom, where regulators are not so directly involved in assessing a challenge study beforehand. The challenge agent also has to be produced under very stringent protocols. So that's a drawback.

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Nature Reviews Genetics (2010). Link The second decade of synthetic biology: 2010–2020 , by Meng F. & Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Nucleic Acids Research (2010). Science (2010).

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Nature Reviews Genetics (2010). Link The second decade of synthetic biology: 2010–2020 , by Meng F. & Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Nucleic Acids Research (2010). Science (2010).

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