Our entire family has been collectively holding our breath, awaiting for action from the U.S. Food and Drug Administration (FDA). Last week, the FDA issued guidance for scientists and device manufacturers seeking approval for artificial pancreas technologies. It was a monumental shift in governmental policy that helps to flatten the regulatory hurdles that could hamper the delivery of groundbreaking treatments for my wife, daughter and anyone else suffering from Type 1 diabetes.
This outcome didn't happen without ALOT of regular, patient advocates rallying around the issue. Over 100,000 signed the artificial pancreas petition to urge the FDA and our Congressional representatives to ACT.
Jeffrey Brewer, whose son Sean has T1, is another"daddybetic." Coincidentally, Jeffrey also serves as CEO of JDRF received the news by saying that "the FDA has been responsive and listened to the recommendations of leading clinicians and researchers in the type 1 diabetes field."
Kudos to the FDA for listening and taking the time and resources to understand the hardships of the diabetes community. And equally big kudos to those of us who made our voices heard.
4 comments:
Agreed, it is reassuring to see the FDA finally coming through on that. Hope it's a sign for the future!
Michael, hopefully the FDA follows through with their guidance and ACTS quickly to get these new trials moving ahead and ultimately get products in the hands of patients who need them!
It certainly is a step forward, and that is something! I totally agree...kudos to the FDA!
So good to have good news!
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