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Merck PedvaxHiB and Comvax Shortage Continues

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FDA reports that an ongoing shortage involving Mercks PedvaxHiB and Comvax vaccines will not be resolved until mid-2009.

Quick Action Not Expected on Biosimilars Bill

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Sen. Kennedys spokesperson says that no immediate action is planned on his bill for a biosimilars pathway.

CLOSED FOR THANKSGIVING

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FDA Webviews News Room is closed for the U.S. Thanksgiving Day holidays. We will reopen on Monday, December 1.

Firm Recalls Dietary Supplement with Bumetanide

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Balanced Health Products recalls its StarCaps dietary supplement capsules due to the presence of an undeclared drug ingredient, bu...

MAPP for Joint OND/OSE Meetings

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A new CDER document sets policies, procedures, and responsibilities for regularly scheduled joint safety meetings between new-drug...

FDA Researching TV Ad Phone-Number Use

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FDA releases for comment its research design to test location and wording of a toll-free phone statement in TV ads.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Aerosol Science Labs, American Assn. of Acupuncture, Fuji System, KeraCure, Sara...

Obama Urged to Choose FDA Chief, Properly Fund It

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The Alliance for a Stronger FDA urges President-elect Obama to swiftly nominate an FDA commissioner and provide a proper level of ...

FDA Clears EastMed Bladder-Support Device

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FDA clears an EastMed 510(k) for its Uresta Continence Care product, intended for use in treating women stress urinary incontinenc...

Direct Mailers Omit, Minimize Cedax Risks

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DDMAC warns Shinogi USA over claims in two direct mailers that minimize risks and expand the indication of its Cedax.