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TVs Boston Legal Portrays Fight for Unapproved Drug Access

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The final episode of televisions Boston Legal portrays real-world FDA review issues and dilemmas faced by dying patients when whac...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Eagle Parts and Products, Hato Portrero Farm, Herbal Hope, IBA Molecular, Lifegu...

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...

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...

Handgun is Not a Medical Device: FDA

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FDA cancels a device registration listing for a companys single-shot handgun after determining that the pistol is not a medical de...

Obama Urged to Appoint Strong Leader to FDA

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Two industry executives call on President-elect Obama to name a strong leader to run FDA and to give the new commissioner sufficie...

Sensible Data Exclusivity Needed for Follow-ons: Calfee

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AEI scholar John Calfee calls for data exclusivity periods of at least 12 to 14 years for follow-on biologics to encourage needed ...

FDA Questions Imagify Safety, Efficacy

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FDA asks the Cardiovascular and Renal Drugs Advisory Committee for input into safety and efficacy concerns with Acuspheres Imagify...