Determining the regulatory path for a combination product is a difficult task. Even in the USA, which seems to have given the most consideration for and focus on defining and regulating combination products, it still involves much uncertainty.
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Phages, also known as Bacteriophages, are viruses that infect specific bacteria and provoke their death via lytic activity. They are…
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2024 is here and will be a crucial year for your clinical trials in the European Union (EU) and European…
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In our previous posts, we explored software tools used in digital health and set the foundations around potential applications of…
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Previously, we talked about how the EU regulates Software as Medical Device (SaMD), including AI-based software. Given that UK is…
