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Travatan Not Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that Travatan 0.004% was not withdrawn from sale for reasons of safety or effectiveness.

Bill Would Broaden Generic Drug Marketing Exclusivity

[ Price : $8.95]

Sens. Bingaman and Vitter introduce legislation to expand generic drug marketing exclusivity to companies other than first filers.

After 50 Years, Animal Antibiotics Still a Waiting Game

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Consulting editor John Scharmann takes a critical look at FDAs 50-year-long hesitation to curb the growth-promotant, subtherapeuti...

Look at Dietary Supplement Adverse Events: Congressmen

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Two congressmen ask the Government Accountability Office to research and report on dietary supplement adverse event reporting.

Shuren Tells Hearing How to Fix Rising Approval Times

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At a Senate hearing, CDRH director Jeff Shuren provides his perspective on how to reduce rising medical device approval times.

CooperVision Expands Contact Lens Recall

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CooperVision says it is now recalling some lots of its Avaira Sphere contact lenses.

QS Violations Found at Taiwanese Medical Device Firm

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FDA warns Taiwans Vega Technologies about Quality System violations in its manufacturing of nebulizers and thermometers.

Distribution of Pennsaid Samples Stopped

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FDA asks Mallinckrodt to stop distributing 15 mL sample bottles of Pennsaid due to reports of improper administration by patients.

Bill Would Limit Commissioners Terms, Boost Innovation

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Sen. Kay Hagan proposes legislation to set a fixed six-year term for the FDA commissioner and create new drug approval pathways.

FDA Clears Calix PC Spinal Implant System

[ Price : $8.95]

FDA clears an X-Spine 510(k) for the Calix PC Spinal Implant System, an intervertebral body fusion system.