A new set of questionnaires have been qualified by the US Food and Drug Administration that the agency says could help it come to a decision when reviewing artificial pancreases. Results from the questionnaires are intended to allow regulators to better understand if the new device is significantly improving quality of life for patients with type 1 diabetes and their care takers.
In recent years the FDA has touted patient reported outcomes data as helpful information that go beyond clinical data to give the patient perspective on a product. More specifically, the...