Topic: Food and Drug Administration
CHICAGO (Reuters) - The U.S. Food and Drug Administration issued new guidelines to medical device makers developing a potentially revolutionary device for type 1 diabetes, saying they should speed its delivery to patients.The guidelines reflect months of behind-the-scenes negotiations with patient advocates, ...
CHICAGO (Reuters) - The U.S. Food and Drug Administration issued new guidelines on Thursday for the development of a potentially revolutionary device to treat type 1 diabetes that will give manufacturers 'maximum flexibility' in getting it to U.S. patients.The guidelines reflect months ...
CHICAGO (Reuters) - It's a dream of medical science that looks tantalizingly within reach: the artificial pancreas, a potential breakthrough treatment for the scourge of type 1 diabetes.Meant to mimic the function of a real pancreas, the artificial version is a complex ...
SILVER SPRING, Maryland (Reuters) - U.S. advisers rejected a new type of diabetes pill from AstraZeneca and Bristol-Myers Squibb over concerns about liver and cancer risks.A Food and Drug Administration advisory panel voted 9-6 on Tuesday against recommending approval of the drug, ...
CHICAGO (Reuters) - Researchers are coming closer to developing an "artificial pancreas," a long-sought system of insulin pumps and glucose sensors that deliver insulin to diabetics, mimicking the function of a real pancreas.The devices have been in development for more than three ...
CHICAGO (Reuters) - Researchers are coming closer to developing an "artificial pancreas," a long-sought system of insulin pumps and glucose sensors that deliver insulin to diabetics, mimicking the function of a real pancreas.The devices have been in development for more than three ...
An anti-depressant and a cholesterol lowering drug, taken together by as many as one million people in the United States, may cause a spike in blood sugar levels, researchers said Wednesday.Paxil and the anti-cholesterol drug Pravachol do not have this effect when ...
NEW YORK (Reuters) - Johnson & Johnson, which has been beset by a seemingly endless stream of product recalls, has recalled hundreds of thousands of potentially leaky insulin pump cartridges that could lead to serious health problems and death.It also has been ...
NEW YORK (Reuters Health) - In a new study, portable meters used to gauge blood sugar levels in pregnant women with diabetes gave readings that differed from lab tests by up to 16 percent.That kind of inaccuracy is concerning, researchers say, because ...
(Reuters) - Inhaled-insulin developer MannKind Corp said the U.S. health regulator would not be able to complete the review of Afrezza by December 29 and would require about four more weeks.The company said it was notified of the delay by the U.S. ...