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Senate passes BioShield; $5.6B slated for industry; FDA initiative seeks to speed up approvals; OHRP to require IRB registration.
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A federally funded national clinical trials registry may soon be a reality if the American Medical Association (AMA) and several Democratic senators have their way.
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At institutions across the country, research administrators now are using Internet-based or local computer software modules to facilitate annual education in human subjects protections for investigators and IRB members.
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IRB Advisor asked IRB and human subjects protection experts from across the nation to discuss the state of human subjects protection regulations and how IRBs are interpreting federal requirements. This article, which is the last in the three-part series, will discuss investigator certification and training.
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Emergency research may raise a number of issues for IRBs that either review such protocols or are asked to assess criteria for emergency room use of an investigational drug or device, experts say.
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As part of its ongoing association studies in several cardiovascular indications, Celera Diagnostics (Alameda, California) has presented data linking genetic variations in two genes with increased risk for myocardial infarction (MI), commonly known as heart attack.
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Angeion (St. Paul, Minnesota) said Richard Jahnke, president and chief executive officer of Angeion and its Medical Graphics subsidiary, plans to retire at the end of the fiscal year on Oct. 31. Jahnke became CEO of Medical Graphics in August 1998 and CEO of Angeion in January 2000 after Angeion acquired Medical Graphics the previous month. The board of directors has selected Rodney Young to succeed Jahnke. Young was most recently president and CEO of LecTec.
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In an agreement that appears to bolster the growing trend toward medical device/biotechnology combination products, device giant Medtronic (Minneapolis, Minnesota) and Genzyme (Cambridge, Massachusetts), a large biotech company that focuses on rare genetic diseases as well as other disorders, have formed a joint venture to accelerate the development of new treatments for some of the most intractable forms of cardiovascular disease.
