All North America articles
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JournalFDA comparability guidance: The impact of cell and gene therapy products
This article analyses FDA draft guidance and other guidance documents and aims to address concerns about CGT products.
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JournalDiversity in clinical research: Regulatory considerations and updates
This article explores how to improve diversity and patient representation in clinical trials and looks at guidance from the EMA.
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CommentaryCell and gene therapy rare disease drug development in the US – general principles, challenges and a landscape of mutual regulatory concession
Cell and gene therapy rare disease drug development in the US – general principles, challenges and a landscape of mutual regulatory concession
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Industry newsUS could ‘seize’ drug patents with unused Reagon-era law
The Biden administration sets new policy direction that could see the US federal government ‘seizing’ patents from publicly-funded medicines.
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Industry newsRapid COVID-19 breath test device shows promise
A small, COVID-19 breath test device – developed by researchers from Washington University, St. Louis– can detect the SARS-CoV-2 virus.
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Industry newsFDA's Emerging Technology Programme
The FDA’s Emerging Technology Programme intends to assist industry in gaining regulatory approval for innovative technology drug applications.