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FDA Sends Warning Letters To Canned Food, Egg, And Ice Cream Processors

2014-11-25 16:27:07| dairynetwork News Articles

The U.S. Food and Drug Administration has issued warning letters to three food-processing facilities including canned food, eggs, and ice cream plants regarding a variety of current good manufacturing practices and other manufacturing violations.

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FDA OKs Valeant\'s New Acne Treatment

2014-11-25 06:00:00| Happi Breaking News

Onexton Gel expected to launch in early 2015.

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Bayer: FDA will speed review of 2 respiratory...

2014-11-25 04:15:44| Chemicals - Topix.net

Two medicines Bayer HealthCare Pharmaceuticals Inc. is testing for respiratory disorders will get priority review by U.S. regulators and other benefits under a 2012 program to boost development of new antibiotics. Bayer HealthCare, based in Whippany, New Jersey, said Monday the Food and Drug Administration has designated two of its experimental treatments as qualified infectious disease products.

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Covidien's Fortrex PTA Balloon Receives FDA 510(k) Clearance

2014-11-25 00:06:10| Industrial Machines - Topix.net

Covidien plc today announced U.S. Food and Drug Administration 510 clearance for its Fortrexa over-the-wire percutaneous transluminal angioplasty balloon catheter. The Fortrexa 0.035" OTW PTA balloon catheter -the next-generation high pressure solution to maintain arteriovenous access-is also intended for use in the peripheral vascular system.

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Gilead Buys Shortcut For FDA Drug Review For $125 Million

2014-11-20 19:13:00| Biotech - Topix.net

How much is a fast track for the Food and Drug Administration review of a new drug worth? Try $125 million. In an auction, Gilead Sciences, a maker of HIV and hepatitis medicines, just bought a coupon good for the accelerated review of a drug of the company's choice from Knight Therapeutics, a Canadian company.

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