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FDA Clears CNSystems Continuous BP Monitor

[ Price : $8.95]

FDA clears a CNSystems Medizintechnik 510(k) for the CNAP Monitor 500, intended for measuring continuous blood pressure in real-ti...

Pixantrone Rolling NDA Planned

[ Price : $8.95]

Cell Therapeutics will start a rolling NDA in 2009 for its pixantrone.

Plavix Doesnt Mix Well With PPIs

[ Price : $8.95]

Medco Health Solutions researchers say that taking a proton pump inhibitor along with Plavix may interfere with Plavix anti-platel...

Von Eschenbach Defends Preemption

[ Price : $8.95]

Skirting the nub of the preemption issue now pending in the Supreme Court, FDA commissioner Andrew von Eschenbach says FDA must ha...

GSK to Resubmit Solzira NDA

[ Price : $8.95]

GlaxoSmithKline says it has withdrawn its Solzira NDA and will resubmit it with trial data reformatted as requested by FDA.

FDA Raising Civil Money Penalties for Inflation

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FDA issues a direct final rule to adjust for inflation the maximum civil money penalty amounts it can impose.

Info on Condom Labeling Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA sends a proposed collection of information on a Class 2 special controls guidance on labeling for nat...

Ethex Recalls 5 Generics

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Ethex recalls specific lots of five generic drugs that may contain oversized tablets.

Review Period Set for Ixempra

[ Price : $8.95]

Federal Register Notice: FDA determines the regulatory review period for patent extension for Bristol-Myers Squibbs Ixempra.

Review Period Set for Tykerb

[ Price : $8.95]

Federal Register Notice: FDA determines the regulatory review period for GlaxoSmithKlines Tykerb for the purpose of patent extensi...