As you know, JDRF conducted an extensive advocacy campaign
in 2011 which resulted in FDA
release of draft artificial pancreas guidance
in December. Since then, our team has
completed a thorough analysis of the FDA draft, speaking with many
experts. Overall, we still remain very
encouraged by the guidance – it lays a reasonable pathway for performing AP
research in the U.S. and for getting this critical technology to people with
T1D. However, we have identified several
areas where revisions to the guidance are needed. We plan to submit comments shortly to FDA
using the on-line comment
Based on our recent discussions with FDA
officials, they are eager to receive feedback, and plan to finalize this and
the low glucose suspend (LGS) guidance in the coming months. Below is a summary of our thoughts.
There are seven things that we find positive in the draft
identified three issues that need to be modified in the final version of the
Our comments to FDA will also include other technical suggestions
Following the comment period, we
will continue to work with FDA as they finalize both this as well at the LGS
guidance. We look forward to providing
more updates in the coming months.
Campbell HuttonDirector, Regulatory Affairs- DevicesJDRF
This is really encouraging news!!
I hope that the FDA will use the guidelines suggested by JDRF to ensure that the artificial pancreas is approved and able to help those who need it. It is exciting that both are in reach and I know they will help my child have a more "normal" life. :-) Thank you JDRF!