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Panel to Discuss Organogenesis BLA

[ Price : $8.95]

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.

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 Proposes Orphan Drug Clarifications and Changes

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FDA lists 13 changes and clarifications it proposes making to the current orphan drug regulation.

FDA Clears Crospon Endoscopic Accessory

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FDA clears a Crospon 510(k) for its EF-800 external channel endoscopic accessory.

Class 1 Recall of CareFusion Ventilators

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FDA classifies as Class 1 a CareFusion recall of 128 EnVe ventilators affecting 29 customers.

Info on Safe Online Drug Purchases Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on educating consumers to safety purchase drugs online.

Info on Substances Prohibited in Animal Feed Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on substances prohibited in animal food or feed to the O...

FDA Clears Siemens Vitamin D Assay

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