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Omnipod with app.

Insulet will now be able to market their continuous insulin delivery system as an integrated insulin pump.

The Evolution of Real-World Evidence in Drug and Device Development

At the T1D Exchange annual meeting, two FDA officers discuss the changing regulatory landscape for drugs and devices.

FDA Approves Eversense CGM for Non-Adjunctive Use

Users of the CGM soon will no longer need fingersticks to verify blood glucose readings before making management decisions.

Eylea Injection for Diabetic Retinopathy Receives FDA Approval

The new treatment received approval after positive results were released earlier this year from the PANORAMA trial.

FDA Releases Guidance on Biosimilars

Drug developers now have the guidelines to understand which studies and considerations are needed to demonstrate that their biosimilar is interchangeable with a reference product.

The agency says it has received word of an accidental insulin overdose that occurred with an automated insulin dosing system.

DOC advocates

by The diaTribe Foundation team Twitter summary: We provide our recap of the Nov.3 virtual discussion w/ the FDA here! Stay tuned for more information coming soon! After hours of planning and anticipation, we were thrilled to see all of the hard work of the diabetes community culminate in the unprecedented patient discussion with the […]

dreamboat2

On April 1, 2014, an advisory panel of US regulatory advisors for the FDA voted that it should approve Afrezza for both type 1 and type 2 diabetes. Keep in mind, however, that the FDA does not have to follow the recommendations of this panel, but it’s an extremely positive sign moving forward. One of […]