FDA Releases Draft Guidance for Artificial Pancreas

Yesterday was a big step in the process of an artificial pancreas.  You may have your opinions of an artificial pancreas, and that it’s not a cure.  You’re right, it is not a cure, but if it makes your life as a diabetic better, than I am all for it.  This thing is long, so if you don’t like to read long documents, than just wait a few days for the experts to go through it.  The JDRF will be releasing some expert notes and reviews of this draft in the next few weeks.

JDRF CEO and President Jeffrey Brewer is quoted as saying:

“Our initial review of the draft AP guidance indicates that the FDA has been responsive and listened to the recommendations of leading clinicians and researchers in the type 1 diabetes field.  It also appears that the draft guidance lays out a rapid timetable to move from inpatient trials to outpatient trials to prove the AP’s safety and efficacy, and if that turns out to be the case it is good news.”

You can find this guidance document for the artificial pancreas over at the FDA.