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Artificial Pancreas Guidance Allows For More Flexibility In Trial Design

FDA’s final guidance on the design and clinical study of artificial pancreas systems broadens the study endpoints permissible for the devices, which aim to “close the loop” in the treatment of type 1 diabetes.

FDA incorporated feedback from the diabetes community in a final guidance document on artificial pancreas systems to allow for more flexibility in the design of clinical trials of the devices.

The Nov. 9 document finalized what had been two distinct draft guidance documents – a December 2011 proposal on clinical...

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