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NEJM Study Deems CRP Significant, Compared With Other Cardiac Markers

This article was originally published in The Gray Sheet

Executive Summary

A recent New England Journal of Medicine study identifying C-reactive protein as a significant marker of coronary heart disease risk may prove to be a boon for CRP diagnostic manufacturers

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Regulatory News In Brief

Calling MDUFMA stakeholders: Reauthorization and potential modification of the Medical Device User Fee and Modernization Act of 2002, which expires after fiscal year 2007, will be the focus of the third annual MDUFMA stakeholder meeting in Gaithersburg, Md. Nov. 17. Agenda items include the user fee structure, premarket review performance goals and the third-party inspection program. Attendees must register online by Oct. 28...

Regulatory News In Brief

Calling MDUFMA stakeholders: Reauthorization and potential modification of the Medical Device User Fee and Modernization Act of 2002, which expires after fiscal year 2007, will be the focus of the third annual MDUFMA stakeholder meeting in Gaithersburg, Md. Nov. 17. Agenda items include the user fee structure, premarket review performance goals and the third-party inspection program. Attendees must register online by Oct. 28...

NIH/Biosite Licensing Agreement Proposed For Atherosclerosis Gene Markers

Biosite is contemplating exclusively licensing genetic markers from the National Institutes of Health for the early diagnosis of coronary artery disease

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