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CDER Supply Chain Program Setting its Priorities

[ Price : $8.95]

CDERs new program to mitigate threats to the drug supply chain starts small, without a budget, by determining its strategic plan, ...

Medtronic Tricuspid Annuloplasty Ring Cleared for Use

[ Price : $8.95]

FDA clears a Medtronic 510(k) for the Tri-Ad Semi-Flexible Tricuspid Annuloplasty Ring for treating tricuspid valve disease.

Companies to Screen the Doctors They Pay

[ Price : $8.95]

Several drug companies tell ProPublica they are taking steps to learn about disciplinary actions taken against doctors they pay to...

FDA Warns of Needleless Pre-filled Glass Syringe Problems

[ Price : $8.95]

FDA advises healthcare professionals about reports of incompatibility, breaking or clogging of certain needleless pre-filled glass...

Companies Want Clearer Suicide Spectrum Definition

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Companies ask FDA for further clarification and revision in the agencys guidance on assessments for suicidal ideation and behavior...

Panelists Say Gardasil Effective for Anal Cancer

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Most members of FDAs Vaccines and Related Biological Products Advisory Committee say Mercks Gardasil appears effective in preventi...

Pressure Wound Therapy Device into Class 2

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Federal Register Final rule: FDA classifies the non-powered suction apparatus device for pressure wound therapy into Class 2 (spec...

COPD Group to Submit Data to FDA

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A COPD Biomarkers Qualification Consortium is assembling data on potential biomarkers to submit to FDA.

FDA Clears Luminex CYP2D6 Genetic Test

[ Price : $8.95]

FDA clears a Luminex 510(k) for a pharmacogenetic test called xTAG CYP2D6 Kit.

Companies Turning to Online Detailing, Events

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SDI says drug companies promoted more than 150 drugs through online details and events for the first time in 2010.