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US And EU Systems For Personalized Medicine: Paths Diverging?

 
• By Amanda Maxwell

There are changes afoot in the regulation and reimbursement policy for IVDs in the EU and US. When it comes to personalized medicine, and companion diagnostics in particular, are the two markets becoming more polarized? Medtech Insight asked US- and EU-based attorneys at Hogan Lovells.

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Changes in the regulation of IVDs in Europe could result in growing differences between how the EU and US regulate personalized medicine, including companion diagnostics. That is the view of Hogan Lovells' US-based life-sciences and health-care partner, Randy Prebula.

Prebula, who focuses on US FDA device and IVD issues, said in an interview with Medtech Insight that there is...

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• By Marion Webb, Brian Bossetta, Natasha Barrow, Elizabeth Orr, and Shubham Singh

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