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Elan, Eisai Paying for Off-label Zonegran Promotion

[ Price : $8.95]

The Justice Department says Elan and Esai and paying $214 million to resolve off-label promotion allegations involving Zonegran.

McNeil's GMP Troubles Continue to Grow

[ Price : $8.95]

A new FDA inspection report adds to the troubles facing McNeil Consumer Healthcare.

Court Upholds Purdue Executives Exclusion

[ Price : $8.95]

A DC federal judge upholds the exclusion of three Purdue Frederick executives from participating in federal healthcare programs fo...

Parallel Review Can Hurt Innovative Device Companies: MDMA

[ Price : $8.95]

MDMA says a FDA/CMS parallel review process could hurt patient care and innovation.

St. Jude Replaces Silicone ICD Leads with Optim Leads

[ Price : $8.95]

St. Jude Medical says it is phasing out its Riata and Riata ST family of defibrillation leads which use silicone as the outer insu...

FDA Seeking End to Avastin Breast Cancer Indication

[ Price : $8.95]

Under immediate House Republican denunciation, FDA recommends that the Avastin breast cancer indication be removed from labeling a...

Advisors Suggest a Partial Ban on Dental Amalgam

[ Price : $8.95]

Members of CDRHs dental advisory panel exceeding their mandate suggest banning use of dental amalgam in children.

New Blood Collection System Cleared

[ Price : $8.95]

FDA clears a Fenwal 510(k) for its Alyx component collection system that is designed with new wireless data export capabilities.

Review Period Set for Angiomax

[ Price : $8.95]

Federal Register Notice: FDA determines the regulatory review period for The Medicines Companys Angiomax for the purpose of patent...

Small Entity Compliance Guide for Supplements

[ Price : $8.95]

Federal Register Notice: FDA releases a small entity compliance guide on CGMPs in manufacturing, packaging, labeling or holding op...