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Science Quality is Key to FDAs Future: Torti

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FDA principal deputy commissioner and chief scientist Frank Torti discusses the importance of science to success in the agencys mi...

Gottlieb Challenges Value of REMS

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AEI resident fellow and former FDA deputy commissioner for medical and scientific affairs Scott Gottlieb calls for scientific vali...

Amylin/Lilly Expect Review Extension on Byetta

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Amylin Pharmaceuticals and Eli Lilly say they expect FDA will extend its review into 2009 on an NDA for Byetta (exenatide) injecti...

Supplements Group Pushes FDA Reform

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The American Association for Health Freedom petitions Congress to totally overhaul and restructure FDA so it will give consumers m...

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 ...

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...

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...

Not Waiting for Obama, CDER Pushes New Goals

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CDER director Janet Woodcock and OND director John Jenkins unveil new efforts on e-submissions, improving Center culture, review t...