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FDA Panel Backs Takeda Gout Drug

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FDAs Arthritis Drugs Advisory Committee recommends approval of a Takeda NDA for Uloric (febuxostat), indicated for treating hyperu...

Japanese Device Plant Has Quality Problems

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CDRH warns Fuji System Corp. on quality problems at its Tokyo balloon catheter manufacturing facility.

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 ...

Page Debarred

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Federal Register Notice: FDA issues an order permanently debarring Dr. Roy Page from providing services to anyone with an approved...

ThermoGenesis Expands Bagset Recall

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ThermoGenesis expands a medical device removal to include six lots of its AXP Processing Bagset.

FDA Seeking Diabetes Drug Safety Data

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TheStreet.com says FDA is asking drug companies to provide cardiac safety data for all diabetes drugs now in clinical trials.

Study 14 Drugs Off-label Use: Researchers

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Researchers suggest 14 drugs that need to be studied for heavy off-label use without sufficient scientific evidence of effectivene...