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Advisors Nix Acuspheres Imagify

[ Price : $8.95]

FDAs Cardiovascular and Renal Drugs Advisory Committee says Acuspheres Imagify doesnt offer enough benefit to overcome its risks....

CGMP Problems Found at Whitney Labs

[ Price : $8.95]

FDAs Florida District Office warns Whitney Labs of multiple CGMP violations at its prescription drug repackaging and relabeling fa...

FDA Consent Decree with Wilderness Family Naturals

[ Price : $8.95]

Wilderness Family Naturals signs a consent decree to stop promoting products for treating diseases.

Hospira Recalls One lot of Potassium Chloride

[ Price : $8.95]

Hospira recalls one lot of 20 mEq potassium chloride in 5% dextrose and 0.45% sodium chloride injection, USP in 1000 mL flexible p...

Additional Oritavancin Study Needed

[ Price : $8.95]

FDA says Targanta Therapeutics oritavancin NDA is not approvable without an additional clinical study that demonstrates its safety...

Blood Panel to Meet

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Federal Register Notice: FDAs Blood Products Advisory Committee will meet 1/9/09 to discuss BLAs from CSL Behring and GTC Biother...

Commissioner Should Have No Industry Ties: Professor

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Boston University professor Alan Cohen says the Obama administration should appoint an FDA commissioner who has no ties to any reg...

Compounding Violations at Stevens Pharmacy

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FDAs Los Angeles District Office warns Stevens Pharmacy that it is manufacturing new and misbranded drugs in excess of what is per...

Merck Planning 3 NDAs in 2009

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Merck says it will submit three NDAs to FDA next year for migraine, acute heart failure and dyslipidemia agents.

Waxman Wants to Restrict Some Drug Ads

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New House Energy & Commerce Committee chairman Henry Waxman pushes legislation allowing FDA to block DTC ads in the first years a ...