Topic: Food and Drug Administration

Reuters US Online Report Health News | 2010-03-16 07:00:13

BOSTON (Reuters) - U.S. regulators have requested more information on an inhaled insulin device being developed by MannKind Corp, sending the company's shares down 24.7 percent. MannKind said on Monday that it had received a so-called complete response letter from the Food and Drug Administration, which has been considering whether to approve the product, a whistle-sized device designed ...

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AP Features | 2010-03-15 23:18:22

Medical device maker Boston Scientific said Monday it is suspending sales of its heart-shocking defibrillator implants after failing to alert regulators to changes in manufacturing of the best-selling devices. The company said it uncovered two production changes that were not cleared with the Food and Drug Administration. Medical device makers are required to alert regulators to significant changes in life-sustaining ...

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Reuters US Online Report Health News | 2010-03-15 20:07:53

ATLANTA (Reuters) - Adding a drug that lowers blood fats known as triglycerides to cholesterol-fighting statins provided no additional protection from heart attack, stroke and death from heart disease in patients with Type 2 diabetes, according to data from a large study. The study run by the National Institutes of Health, dubbed Accord, aimed to see if the dual-drug therapy could ...

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AFP Global Edition | 2010-03-15 17:10:27

An experimental ablation therapy system that freezes heart tissue with a balloon catheter to treat a common heart rhythm disorder is far more effective than drug therapy, a study found Monday. Researchers compared the safety and efficacy of the Arctic Front CryoAblation Catheter System produced by US firm Medtronic to drug therapy over at least one year in 245 patients ...

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Implanted Hearing System Approved

HealthScout.com | 2010-03-18 11:48:58

Boston Sci Dips; More FDA Trouble?

Tech Trader Daily | 2010-03-18 11:04:26

FDA to reconsider ban on gays donating blood

ABC 24 Austin (KVUE) | 2010-03-18 10:36:55

FDA Looks to Streamline Rules for New Drug Cocktails

Wall Street Journal Health Blog | 2010-03-18 09:09:48

Health Beat: Government and drug companies trying out new breast cancer drugs

NBC 13 Eau Claire, WI (WEAU) | 2010-03-18 07:57:50

FDA To Devise New Guidelines For Drug Cocktails

Pharmalot | 2010-03-18 09:38:52

FDA Approves First Totally Implanted Hearing System

FDA Press Releases | 2010-03-17 16:16:37

Statement for National Poison Prevention Week

FDA Press Releases | 2010-03-17 16:16:02

FDA Seeks Permanent Injunction Against Louisiana Sprout Grower

FDA Press Releases | 2010-03-17 11:32:28

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