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Asthma Drugs Can Cause Problems: FDA Study

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FDA says long-acting beta agonists prescribed for managing asthma may cause increased risk of asthma complications under certain c...

Panel Asked About Synvisc-One Efficacy, Safety

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FDA asks the Orthopedic and Rehabilitation Devices Advisory Committee to comment on the efficacy and safety of Genzymes Synvisc-On...

Workshop on Sentinel Initiative

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Federal Register Notice: FDA co-sponsors with the eHealth Initiative Foundation a public workshop 12/16 on the Sentinel Initiative...

FDA Panel Backs Bausch Lomb Eye Drops

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FDAs Dermatologic and Ophthalmic Drugs Advisory Committee 12/5 unanimously recommends approval of Bausch & Lomb's besifloxacin oph...

FDA Tentatively OKs 2 Aurobindo ANDAs

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FDA tentatively approves two Aurobindo Pharma ANDAs for generic copies of Solvay Pharmaceuticals Aceon tablets and Forest Laborato...

Advisors Back Lumigan Eyelash Grower

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FDAs Dermatologic and Ophthalmic Drugs Advisory Committee says Allergans Lumigan is safe and effective for cosmetic use to thicken...

Rep Suggested Unapproved Seroquel Use: DDMAC

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DDMAC says an AstraZeneca sales representative misleadingly suggested that Seroquel and Seroquel XR were approved for treating maj...

Republicans Challenge FDA Office of Criminal Investigations

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Leading Republicans on the House Energy and Committee ask FDA commissioner Andrew von Eschenbach to explain why increased funding ...

Sharfstein: Consumer Guidance Needed on OTC Cough Meds

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Baltimore health commissioner and reputed commissioner prospect Joshua Sharfstein says FDA needs to provide clear guidance to pare...

Licensed Biologics Manufacturing Arrangement Guidance

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FDA finalizes a guidance to help biologics manufacturers plan and implement cooperative manufacturing arrangements.