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Animas Class 1 Pump Battery Cap Recall

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FDA says Animas recall of defective insulin pump battery caps is a Class 1 recall.

Harmonized Device Documents Available for Comment

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Federal Register Notice: FDA releases and seeks comments on a harmonized proposal on regulatory requirements for medical devices p...

Essential Use Epinephrine Removed for Inhalers

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Federal Register Final rule: FDA removes the essential use designation for epinephrine in oral pressurized metered-dose inhalers.

Medtronic Complying with Infuse Off-label Subpoena

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Medtronic says it is complying with a Department of Justice subpoena for information on off-label promotion of its Infuse spinal b...

Advisors Back Telavancin for Skin Infections

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FDAs Anti-infective Drugs Advisory Committee says Theravances telavancin is safe and effective for complicated skin and skin struc...

Black Box Warning Needed for Avastin?

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Researchers say it may be appropriate for FDA to add a black box warning on blood clot risk to Avastin labeling.

Sanofi and Barr Settle Patent Suit on Nasacort

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Sanofi-Aventis and Barr Laboratories settle an ongoing patent suit over Barrs ANDA for a generic copy of Nasacort AQ.

FDA Concerned With Drug Heart Risk

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OND director John Jenkins says FDA is re-thinking its approach to clinical trials for drugs used to treat chronic conditions becau...

Obama Selects Former Senator Daschle as HHS Secretary

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President-elect Barak Obama selects former Senate majority leader Tom Daschle as his nominee for Health and Human Services secreta...

Waxman Wins First Round to Unseat Dingell

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Representative Henry Waxman (D-CA) wins a preliminary round to take the chairman seat of the House Energy and Commerce Committee a...