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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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

KV Chairman is First Banned Exec

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The HHS inspector general says KV Pharmaceutical chairman Mark Hermelin is the first drug company executive to be banned from part...

FDA Continues View that Generic Drug Suits Not Preempted

[ Price : $8.95]

FDA tells an appeals court that a lower court ruling that failure-to-warn suits against manufacturers of generic Reglan are preemp...

FDA Grants ISTA 3-year Exclusivity for Bromday

[ Price : $8.95]

FDA grants ISTA Pharmaceuticals three years marketing exclusivity under the Hatch-Waxman Act for eye drug Bromday.