All North America articles
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JournalA year of change for the US FDA: An update on notable pilots and programmes
This article updates on the FDA’s pilots and programmes that have been launched and also ongoing projects in 2025.
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ContentsRegulatory Rapporteur December 2025 – Contents
The December issue of Regulatory Rapporteur focuses on North America.
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JournalNavigating the landscape of paediatric clinical trials under US FDA guidelines
This article explores paediatric clinical trials under the guidelines of US Food and Drug Administration (FDA) legislation, focusing on research development and ethics.
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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This article analyses FDA draft guidance and other guidance documents and aims to address concerns about CGT products.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.