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FDA Archives

FDA

Updated 4 days ago
Prodigy Diabetes Care Moves Forward After FDA Concludes Regulatory Action

CHARLOTTE, N.C., April 16, 2014 /PRNewswire/ -- On April 10, 2014 the U.S. Food & Drug Administration (FDA) issued a "Closeout" letter to Prodigy Diabetes Care to formally conclude the regulatory action that resulted in a Warning Letter on February 22, 2013.

Comments 0 comments - Apr 21, 2014 - * * * * *

Inhaled Insulin to Treat Diabetes Earns FDA Committee Recommendation

The inhaled insulin Afrezza has been recommended for approval by a Food and Drug Administration (FDA) advisory committee.

Comments 0 comments - Apr 12, 2014 - * * * * *

FDA Delays Final OK for Type 2 Drug Empagliflozin

The FDA will delay allowing the type 2 drug empagliflozin to enter the U.S. market until "previously observed deficiencies" at the plant where it is manufactured are fixed.

Comments 0 comments - Mar 23, 2014 - * * * * *

FDA Backtracks Over GLP-1s' Effects on Pancreas

The U.S. Food and Drug Administration reports that its review of various animal and human studies does not show a link between GLP-1 drugs used to treat type 2 diabetes and pancreatic maladies, including acute pancreatitis and pancreatic cancer.

Comments 0 comments - Mar 4, 2014 - * * * * *

More Than 180 New Diabetes Drugs in Development

A total of 182 new drugs to treat diabetes or diabetes-related conditions are currently in clinical trials or undergoing review by the U.S. Food and Drug Administration, according to a report just published by the Pharmaceutical Research and Manufacturers of America (PhRMA).

Comments 0 comments - Mar 1, 2014 - * * * * *

FDA Approves Dexcom G4 Platinum CGM Use for Children 2-17

The U.S. Food and Drug Administration has approved the expanded use of the Dexcom G4 Platinum Continuous Glucose Monitoring System for patients with diabetes ages 2 to 17 years. The G4 Platinum System, which monitors blood glucose levels in people with diabetes, had been approved for patients ages 18 and older.

Comments 0 comments - Feb 4, 2014 - * * * * *

FDA Proposes Separate Guidelines for Home vs. Clinical Glucose Meters

The Food and Drug Administration is proposing separate guidelines for over-the-counter blood glucose meters compared to those used at the doctor's office or in other healthcare settings.

Comments 0 comments - Jan 23, 2014 - * * * * *

Type 1 Drug Wins Orphan Status

DV-100, a drug designed to halt the body's autoimmune attack on pancreatic beta cells that leads to type 1 disease, has won orphan drug status from the U.S. Food and Drug Administration.

Comments 0 comments - Jan 16, 2014 - * * * * *

FDA Opens Way for Diabetic Macular Edema Device

The Food and Drug Adminsitration, reversing itself on a decision it made in October, has opened the way for a new treatment for diabetic macular edema to reach the U.S. market.

Comments 0 comments - Jan 1, 2014 - * * * * *

Is High Fructose Corn Syrup “the New Trans Fat"?

The non-profit consumer action group Citizens for Health earlier this month called on the Food and Drug Administration to do its part in raising awareness of the dangers of high fructose corn syrup by making an official statement recognizing the sweetener as an unsafe addition to the nation's food supply.

Comments 0 comments - Dec 13, 2013 - * * * * *

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