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The FDA has denied two citizen petitions filed on behalf of the Informed Consent Action Network (ICAN) requesting the agency revoke its...
Cortex - Life Sciences Insights
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We first wrote about the planned amendments to the Pharmaceutical Law and certain other acts (the so-called Verticalisation Act) in...
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The FDA recently published “Sameness Evaluations in an ANDA – Active Ingredients,” a new draft guidance detailing recommendations for...
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As someone who believes strongly in empowering women in the workplace and building a diverse and inclusive culture, I really enjoyed...
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Published in Chambers Expert Focus US partner Lauren Murdza and UK partner Richard Taylor share their insights on supply chain issues in...
This week our Life Sciences team published the first edition of its Cross-border Guide to Clinical Trials and Privacy. The Guide will...
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Artificial intelligence (AI) is playing an increasingly relevant and important role in our lives. Be it through your personal devices,...
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The SPAC structure not only enables the target companies to be listed in the United States’ public stock market through a simpler and...
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With the mounting mental health crisis intensified by the COVID-19 pandemic, the telemental health industry has exploded in recent years....
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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...
