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Clinical Investigator Training Course Planned

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Federal Register Notice: FDAs Office of Critical Path Program and the Clinical Trials Transformation Initiative will hold a traini...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Boca Pharmacal, CeraSys, IriSys, Steril-Aire, and Terry Yon & Assoc. dba TYA Pha...

Marketing Can Lower Drug Costs: Ehrlich

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Drug marketing gurus Bob Ehrlich and John Mack debate the state of DTC marketing in an Internet radio broadcast.

Panel to Discuss Aranesp Study

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Federal Register Notice: FDAs Cardiovascular and Renal Drugs Advisory Committee will meet 10/8 to discuss the TREAT study of Amgen...

FDA Awards 2 Minor Animal Drug Research Grants

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FDA announces the award of two new animal drug research grants for minor use/minor species studies in Iowa and Montana.

FDA Orphan Status for Infantile Spasm Drug

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FDA grants Catalyst Pharmaceutical Partners an orphan drug designation for CPP-115, a novel GABA aminotransferase inhibitor for tr...

Six Associations Publish Live Case Demo Statement

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Six cardiovascular societies worldwide issue guidelines on live case demonstrations with a companion FDA document.

Apricus Finalizing RayVa Phase 3 SPA for FDA

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Apricus Biosciences says it will submit for FDA review a Phase 3 SPA trial for its RavVa to treat Raynauds syndrome secondary to s...

FDA Updates Hospira's Infusion Pump Recall

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FDA updates a Hospira Class I recall involving its Symbiq One and two Channel Infuser infusion pumps to reinforce mitigation steps...

FDA Clears Phadia Assays for Celiac Disease

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FDA clears a Phadia 510(k) for the EliA GliadinDP IgA and EliA GliadinDP IgG (deamidated peptides) assays for use in diagnosing Ce...