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. Click
here for a summary of the panel’s recommendations.
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.