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When clinical trials for new drug approvals fail to adequately represent racial and ethnic groups, there is a lost opportunity to collect...
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In the wake of FDA’s long-awaited final guidance for the regulation of Clinical Decision Support Software, many software developers and...
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Yesterday (20 October 2022), Advocate General (AG) Kokott of the European Court of Justice issued her Opinion in relation to the appeal...
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The Inflation Reduction Act (IRA) significantly impacts the US economic model for prescription drug innovation through the imposition of...
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Our EU Life Sciences Regulatory team led by Marco de Morpurgo and Nicola Landolfi have produced a guide on EU Pharma & Medical Device...
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In our latest report, we provide an update on the key legislative changes proposed and introduced in the pharmaceutical sector in Poland.
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New technologies based on human cells are increasingly seen as key to reducing the time and cost in bringing drugs to market. This is an...
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The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical...
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Clinical Decision Support (CDS) software is an area driven by innovative technologies that is often intertwined with traditional clinical...