EMA commentary on the guideline on quality, nonclinical and clinical aspects of medicinal products containing genetically modified cells
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DOI: 10.1111/bcp.16047
Abstract: Great advances have been made in the knowledge of development and regulatory approval of medicinal product containing genetically modified cells. Although a guideline has been available in the EU since 2012, the current updated version… read more here.
Keywords: modified cells; genetically modified; commentary guideline; ema commentary ... See more keywords