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FDA Warns Public of Possible Botulism Risk
The U.S. Food and Drug Administration (FDA) announced that New Era Canning Company, New Era, Mich., is expanding its product recall because of potenti...

FDA Approves Update to Label on Birth Control Patch
The U.S. Food and Drug Administration (FDA) today approved additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to includ...

FDA puts AeroLEF pain drug study on hold
YM BioSciences said it has been informed by the US Food and Drug Administration that the regulator has put on hold the Phase II Acute Pain Study of Ae...

FDA Clears First Quick Test For Drug-Resistant Staph Infections
The U.S. Food and Drug Administration (FDA) announced it has cleared for marketing the first rapid blood test for the drug-resistant staph bacterium k...

FDA Clears First Test Designed to Detect and Identify 12 Respiratory Viruses from Single Sample
The U.S. Food and Drug Administration today cleared for marketing a test that simultaneously detects and identifies 12 specific respiratory viruses. ...

FDA Commissioner Names Directors to Food Safety Centers
Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., is pleased to announce two major changes in the agency's senior leadership team. Effect...

FDA Receives New Data on Risks of Anemia Drugs
The U.S. Food and Drug Administration (FDA) is reviewing new data from two studies that provide further evidence of the risks of anemia drugs known as...

FDA Okays Samaritan's Cushing's SP-6300 IND and Clears Phase II Study
Samaritan Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has completed its regulatory review of Samaritan's IND (Investiga...

FDA Approves Kuvan for Treatment of Phenylketonuria
The U.S. Food and Drug Administration approved Kuvan (sapropterin dihydrochloride), the first drug of its kind approved to slow the effects of a rare ...

FDA Develops New Tools to Further Improve the Security of Food and Cosmetics
As part of the FDA’s comprehensive Food Protection Plan initiative, the agency today released self-assessment tools for industry to minimize the risk ...

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