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Nominations Sought for Device Panelists

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Federal Register Notice: FDA requests nominations for voting members to serve on several device advisory panels.

FDA Approves Gardasil for Use in Young Males

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FDA approves Mercks Gardasil for preventing genital warts caused by HPV types 6 and 11 in young men.

Group Asks for Recall of All-laser LASIK Devices

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LASIK Surgery Watch says CDRH should recall all-laser LASIK devices that were given 510(k) clearance without rigorous clinical tri...

FDA OKs Elanco Animal sNADA for Cattle Feed

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Federal Register Final rule: FDA approves Elanco Animal Healths sNADA to revise limitations for liquid Type B medicated cattle fee...

FDA Urges Consumer Caution With Internet H1N1 Flu Drugs

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FDA cautions consumers against buying H1N1 flu products over the Internet after the agency bought some and found them to be unsafe...

Hamburg Names New FDA Legislation Chief

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FDA commissioner Margaret Hamburg names House Energy and Commerce chief public health advisor Jeanne C. Ireland as FDAs new assist...

Consumers Worry About Online Drugs

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Lightspeed Research says that 20% of consumers are buying drugs online but worry about the drugs safety.

FDA Clears Biosense Webster Cardiac Imaging System

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FDA clears a Biosense Webster 510(k) for the Carto 3 System, a three-dimensional imaging system for use by electrophysiologists in...

17 Warning Letters Target MDR Reporting at LASIK Sites

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FDA issues 17 Warning Letters to LASIK ambulatory surgical centers after recent inspections revealed that they had inadequate syst...