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Pancreas Cancer

Michael - the FDA was posted 03/01/2010 06:33 am by KarenB
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Michael, Just an FYI, in case you weren't already aware: the reason that drug and device approval almost always takes longer in the US than it does in Europe is because the EU regulatory bodies require that only safety be shown, whereas the FDA requires that safety AND efficacy be shown. To prove that something is efficacious often requires clinical trials with complex biostatistics, and can add years to the approval process (especially if the endpoints chosen to prove efficacity are poorly chosen, which often happens).

So sorry Sherrie is suffering so. Have a safe trip home. Keeping you both in my thoughts and prayers, KarenB



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