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Comments on Allergic Disease Treatment Extended

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Federal Register Notice: FDA extends the comment period on a scientific and medical literature report on the use of non-standardiz...

Panel to Discuss Cranial Electrotherapy Device Reclassification

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Federal Register Notice: FDAs Neurological Devices Panel will discuss 2/10/12 the possible reclassification of cranial electrother...

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.

Bill Would Broaden Generic Drug Marketing Exclusivity

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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...

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.

Woodcock Optimistic on Startlingly Better Therapies

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CDER director Janet Woodcock says she is so optimistic that the 40 years of biomedical science and the war on cancer will be produ...

FDA Dodges Bullet in House/Senate Funding Agreement

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FDA dodges a funding bullet as House and Senate conferees agree to follow the Senates version of the agencys FY 2012 appropriation...