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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...

Companies Should Cooperate with Research: Journal

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A New England Journal of Medicine editorial faults GlaxoSmithKline for refusing to provide drugs and placebos for government-spons...

Companies Recall Supplements with Aromatase Inhibitors

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FDA says five companies are recalling products containing aromatase inhibitors they marketed as dietary supplements.

Risk Communication Panel to Meet

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Federal Register Notice: FDAs Risk Communication Advisory Committee will meet 11/8-9 to discuss ongoing communications programs an...

Franken Presses Hamburg on 510(k) Changes

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Sen. Al Franken calls on FDA to take seriously concerns expressed by Minnesota medical device companies over plans to reform the 5...