Search results for "FDA update"

Results 1 - 10 of about 98 for "FDA update".

FDA issues draft guidance on blood glucose monitors | ACP Diabetes Monthly

The updated recommendations apply to industry and, when finalized, will update previous guidance issued in 2016.

Glucagon recalled due to detaching needles | ACP Diabetes Monthly

Six batches of GlucaGen HypoKit (glucagon [rDNA origin] for injection) were recalled due to the possibility of needle detachment, the FDA recently announced.

Test strips recalled | ACP Diabetes Monthly

Twenty lots of Abbott's FreeStyle and FreeStyle Lite blood glucose test strips were recalled.

Test strips recalled | ACP Diabetes Monthly

The SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip may report falsely low blood glucose levels.

Follow-on insulin lispro approved | ACP Diabetes Monthly

The injection is approved to improve glucose control in patients ages three years and older with type 1 diabetes and in adult patients with type 2 diabetes.

Ertugliflozin approved as adjunct treatment for type 2 diabetes | ACP Diabetes Monthly

As an adjunct to diet and exercise, the drug was approved as monotherapy and for use in fixed-dose combinations with metformin or sitagliptin.

New warnings for fluoroquinolones about risk of hypoglycemic coma | ACP Diabetes Monthly

The labeling changes for fluoroquinolones will also make the mental health side effects more prominent and more consistent across the drug class.

Warning on risks of canagliflozin | ACP Diabetes Monthly

The FDA on Sept. 10 released a strengthened warning on canagliflozin (Invokana, Invokamet) about increased risk of bone fractures and decreased bone mineral density.

SGLT2 inhibitors associated with ketoacidosis | ACP Diabetes Monthly

Sodium-glucose cotransporter-2 (SGLT2) inhibitors, including canagliflozin, dapagliflozin, and empagliflozin, may cause ketoacidosis, the FDA recently warned.

First AI device approved to detect diabetes-related eye problems | ACP Diabetes Monthly

The software analyzes images of the eye taken with a retinal camera and offers one of two results: “more than mild diabetic retinopathy detected: refer to an eye care professional” or “negative for more than mild diabetic retinopathy; rescreen

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