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07 April 2011


Russell Roiko

What is the typical path for devices approved in Europe to get approved in the US?

Philip Needham

Hi Nancy,
I'd treat the "average 7 months in Europe" with caution. Here in the UK the local ethics committees now come under an overarching national body, making involvement of local clinicians difficult and resulting in extended timescales. Other States in mainland Europe seem to have a more pragmatic approach to trials.

Account Deleted

I found this paper very useful, and agree all of them, many thanks, Sule Mene

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