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As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
While the US Food and Drug Administration has been experiencing recent reorganization and cuts in personnel, the United Kingdom has its own upcoming policy changes making it easier and faster to initiate and maintain UK...more
The UK government plans to turbocharge the life sciences sector using policy levers to enhance research and development, innovation hubs, and private fundraising. In this piece, Michael Bloch explores how refinements to...more
The UK government has recently announced that it plans to introduce a Cyber Security and Resilience Bill (Bill). The Bill seeks to update the 2018 Network and Information Security Regulations, which implemented the European...more
The MHRA announced on Tuesday the biggest overhaul of clinical trial regulation in the UK in 20 years. The details of the amendments to clinical trial regulation are set out in the MHRA’s response to a public consultation...more
The guidance provides helpful clarity on key regulatory changes impacting life sciences companies in the event of a no-deal Brexit. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a...more