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FDA Clears Siemens Vitamin D Assay

[ Price : $8.95]

FDA clears a Siemens Healthcare Diagnostics 510(k) for its Vitamin D Total Assay for use on the ADVIA Centaur/XP Immunoassay Syste...

Guilty Plea in Trial Falsification Case

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A Kansas doctor and clinical trial coordinator plead guilty to charges they falsified clinical trial data.

Drug Importation Amendment Added to FDA Spending Bill

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Sen. David Vitter (R-LA) introduces an amendment to allow personal importation of drug products from Canada during floor debate on...

Sanofi Reports Shortage with Insulin Product

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Sanofi and FDA report a temporary shortage of the company's Apidra SoloSTAR insulin pens due to a manufacturing problem in July.

Special Counsel Takes CDRH Whistleblowers Side

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The federal Office of Special Counsel takes the side of a CDRH biomedical engineer who blew the whistle on superiors who approved ...

Individual Case Safety Report Guidance

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FDA publishes an ICH guidance on electronic transmission of individual case safety reports.

Abbott Holding $1.5 Billion for Possible Depakote Settlement

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Abbott discloses a $1.5 billion litigation reserve for use in a possible settlement with the Justice Department of charges that it...

FDA to Amend Orphan Drug Regulations

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Federal Register Proposed rule: FDA proposes to amend the orphan drug regulations to clarify certain provisions and make minor imp...

Panel to Discuss Organogenesis BLA

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Federal Register Notice: FDAs Cellular, Tissue and Gene Therapies Advisory Committee will meet 11/17 to discuss an Organogenesis B...

FDA Corrects Withdrawal of Pfizers Geocillin

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Federal Register Notice: FDA corrects an inadvertent withdrawal of approval of Pfizers Geocillin.