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Baxter Recalls 1 Nitroglycerin Lot

[ Price : $8.95]

Baxter recalls one lot of nitroglycerin in 5% dextrose injection after particulate matter was found in one vial.

Liver-Specific Contrast Agent Gets Orphan Drug

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FDA grants orphan drug status to CMC Contrast AB for its liver-specific contrast agent for diagnostic MRI for detecting liver lesi...

Comments Sought on Importers Entry Notice

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Federal Register Notice: FDA seeks comments on information collection in FDAs Importers Entry Notice.

Comments Extended on Asthma Drug Bioequivalence

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Federal Register Notice: FDA is reopening the comment period Draft Guidance for Industry on Bioequivalence Recommendations for Flu...

Comments Extended on Generic Drug User Fee Guidance

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Federal Register Notice: FDA reopens the comment period on a draft guidance on the generic drug user fee amendments of 2012.

Panel to Discuss REMS Communications

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Federal Register Notice: FDAs Risk Communications Advisory Committee will meet 12/17 to discuss new methods for communication risk...

FDA Seeks Sponsors for Study Data Pilot

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Federal Register Notice: CDER and CBER announce a pilot project to evaluate the Clinical Data Interchange Standard Consortium Subm...

CDRH Class 1 Recall for Hospira GemStar Pumps

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CDRH classifies as Class 1 a recall involving Hospiras GemStar Infusion System.

CLR Medicals Recalls Viscocel Products

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CLR Medicals International recalls its Viscocel and Viscocel Plus products following an FDA inspection that cited deficiencies wit...

Obama Nominates OCI Head Roth as Homeland Security IG

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President Obama nominates FDA Office of Criminal Investigations director John Roth to serve as inspector general of the Department...