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As previously shared when the new regulatory framework for software as a medical device (“SaMDs”) was presented earlier this year (here),...
Cortex - Life Sciences Insights
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With Law Decree no. 115/2022 (Aiuti Bis Decree), the Italian Government reactivated the so-called “payback” system for medical devices....
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In March this year the pharmaceutical companies Juno Pharmaceuticals Pty Ltd (Juno), Natco Pharma Ltd (Natco), and Celgene Corporation...
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President Joe Biden has issued an Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and...
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The Polish government plans to change the legal regulations regarding dietary supplements. The government's adoption of the draft...
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The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued a joint statement on the interchangeability of...
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You wake up early to the sound of an alarm that only exists inside your own head, and it is silenced automatically as soon as you’re...
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Italy enacted legislation to adapt the national framework governing medical devices and in vitro-diagnostic medical devices to the MDR...
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Introduction The benefits of using genetic information for research purposes are clear, especially as the technology underpinning...
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In this episode, DLA Piper partner Danny Tobey is joined by Aviva Wein, Assistant General Counsel at Johnson & Johnson, to discuss how...
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In a paradigm shift for the hearing aid industry and patients, the FDA has finalized a rule to establish a new over-the-counter (OTC)...
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The Brazilian Patent and Trademark Office (BRPTO) efforts to reduce the patent backlog is generating positive results despite the...
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Brazil currently has the third most cases of monkeypox in the world. Until August 20 of this year, 14,054 notifications were registered...
