On its website, ABC News 
(12/1, Moisse, Carollo) reports, "The US Food and Drug Administration today issued guidance for scientists and device manufacturers seeking approval for the artificial pancreas – a portable device to help people with type 1 diabetes control their blood sugar levels." The guidance is "aimed at easing the approval process while still meeting statutory requirements for safety and effectiveness." Jeffrey Brewer, president and CEO of the Juvenile Diabetes Research Foundation and the parent of a son with type 1 diabetes, said that the group's "initial review" of the new guidance "indicates that the FDA has been responsive and listened to the recommendations of leading clinicians and researchers," and that it "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."
(12/1, Moisse, Carollo) reports, "The US Food and Drug Administration today issued guidance for scientists and device manufacturers seeking approval for the artificial pancreas – a portable device to help people with type 1 diabetes control their blood sugar levels." The guidance is "aimed at easing the approval process while still meeting statutory requirements for safety and effectiveness." Jeffrey Brewer, president and CEO of the Juvenile Diabetes Research Foundation and the parent of a son with type 1 diabetes, said that the group's "initial review" of the new guidance "indicates that the FDA has been responsive and listened to the recommendations of leading clinicians and researchers," and that it "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." Reuters (12/1, Steenhuysen) reported that the artificial pancreas appears to be possible, but some advocates fear that regulators could set overly strict testing requirements that might delay its development, such as requiring a new round of testing whenever a single component of the device is facing change. The Juvenile Diabetes Research Foundation advocacy group notes, for instance, that an early Medtronic version of the artificial pancreas, the Paradigm Veo insulin pump, is sold in 50 nations but not the US, and has called the FDA "the biggest bottleneck right now."
(12/1, Steenhuysen) reported that the artificial pancreas appears to be possible, but some advocates fear that regulators could set overly strict testing requirements that might delay its development, such as requiring a new round of testing whenever a single component of the device is facing change. The Juvenile Diabetes Research Foundation advocacy group notes, for instance, that an early Medtronic version of the artificial pancreas, the Paradigm Veo insulin pump, is sold in 50 nations but not the US, and has called the FDA "the biggest bottleneck right now." CQ (12/2, Adams, Subscription Publication) reports that the co-chairwomen of the Senate Diabetes Caucus, Susan Collins (R-ME) and Jeanne Shaheen (D-NH), "noted in a statement that FDA officials had promised them earlier this year that they would issue the guidance by December." Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, "said that the 64-page draft guidance was designed to be flexible," and offers device makers several options in designing trials.
The Los Angeles Times (12/2, Brown) "Booster Shots" blog reports that Shuren "said in a statement that the agency's guidance would 'provide maximum flexibility to manufacturers seeking to bring this device to US patients' while also assuring that the machines would be safe and effective."
(12/2, Brown) "Booster Shots" blog reports that Shuren "said in a statement that the agency's guidance would 'provide maximum flexibility to manufacturers seeking to bring this device to US patients' while also assuring that the machines would be safe and effective." HealthDay (12/1, Reinberg) reports that the device would combine an insulin pump and a continuous glucose monitor to monitor and control blood sugar levels for type 1 diabetes patients and "could make a huge difference" for those patients. At a Thursday news conference, Charles Zimliki, leader of the FDA's Artificial Pancreas Working Groups and Critical Path Initiative, said, "We really are trying to get these devices to the market as quickly as possible."
(12/1, Reinberg) reports that the device would combine an insulin pump and a continuous glucose monitor to monitor and control blood sugar levels for type 1 diabetes patients and "could make a huge difference" for those patients. At a Thursday news conference, Charles Zimliki, leader of the FDA's Artificial Pancreas Working Groups and Critical Path Initiative, said, "We really are trying to get these devices to the market as quickly as possible." MedPage Today (12/1, Fiore) reports that the FDA's guidance addresses two variants of the artificial pancreas: "target-to-range, which keeps blood sugar levels in check when they get too low or too high, and treat-to-target, which attempts to keep levels at a constant mark." Earlier guidance from the agency in June "focused on low-glucose suspend -- an earlier generation technology that automatically shuts down an insulin pump when blood sugar gets too low."
(12/1, Fiore) reports that the FDA's guidance addresses two variants of the artificial pancreas: "target-to-range, which keeps blood sugar levels in check when they get too low or too high, and treat-to-target, which attempts to keep levels at a constant mark." Earlier guidance from the agency in June "focused on low-glucose suspend -- an earlier generation technology that automatically shuts down an insulin pump when blood sugar gets too low." 
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