It has been a little while since we’ve posted on FDA and the artificial pancreas and we thought you might be interested in an update.
As you may recall, FDA and NIH held a public meeting in November on the artificial pancreas. At that meeting researchers, clinicians, and patients all agreed that there is a way forward to take testing of these systems outside of the hospital. Since that meeting, JDRF has been continuing to talk to FDA about the importance of incorporating the recommendations of the experts they heard from into their decision-making. Clear and reasonable guidelines from FDA are essential to stimulate the field even more and encourage more interest, research, and innovation.
At the beginning of January, a few members from JDRF’s clinical panel met with the FDA’s artificial pancreas team to explain their recommendations, answer questions from the FDA staff, and get their input and feedback. FDA was interested in the panel’s recommendations and there was a fruitful discussion.
And, the most exciting development is that JDRF is taking the initiative to compile these recommendations into what’s called a ‘guidance document’ that will be proposed to FDA. We think that, with the recommendations of the clinical panel and the consensus evident at the November meeting, now is the time for FDA to provide a pathway for artificial pancreas development.
Having guidance from FDA will accelerate the ability of researchers and companies to develop this much needed technology for patients with type 1 diabetes. By providing this guidance document to FDA, we hope to help ensure there is a clear and defined regulatory pathway.
We’d love to hear from you below about what you think is important for FDA to consider when they determine how to best encourage innovation in the field of diabetes management technology.
And, don’t forget to tell us why an artificial pancreas is important to you on the APP Tell Your Story page.
If you want to relive or experience for the first time the FDA/NIH public meeting, FDA posted the webcast on its website.