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Accelerating Innovation: FDA Expedited Programs 101
In the fast-paced world of biotech innovation, time is of the essence. For European biotech ventures eyeing entry into the…
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Achieve Success for Your First US Product Application – Pathway to IND
Embarking on the journey to expand into the United States market is a pivotal moment for any European biotech company.…
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A deep dive into the regulatory framework for Phage Medicinal Products
Phages, also known as Bacteriophages, are viruses that infect specific bacteria and provoke their death via lytic activity. They are…
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Sponsors of Clinical Trials in the EU/EEA – Call for Action!
2024 is here and will be a crucial year for your clinical trials in the European Union (EU) and European…
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Digital Health Series – Part 5: Key Challenges for Software and AI as a Medical…
In our previous posts, we explored software tools used in digital health and set the foundations around potential applications of…
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Digital Health Series – Part 4: Software as a Medical Device Regulated by the UK
Previously, we talked about how the EU regulates Software as Medical Device (SaMD), including AI-based software. Given that UK is…
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Demystifying the US IND process for initiation of clinical trials
Submitting an Investigational New Drug (IND) application to the US FDA is a significant step in the development of a…
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The International Recognition Procedure – The United Kingdom’s new route for accelerated marketing authorization
Following the UK’s departure from the EU In 2021, the MHRA has introduced several initiatives to foster product development and…