Originally Published MX January/February 2006
BUSINESS NEWS
FDA in ActionUtah Medical Products Inc. (Midvale, UT) this past fall successfully defended itself against FDA's charges that the company failed to comply with the good manufacturing practices requirements of the agency's quality system regulation. In the end, Utah Medical won a stunning victory when the U.S. District Court in Salt Lake City dismissed the case with a ruling that chided FDA for its actions.
FDA is actively considering the advisability of at-home testing for HIV—a subject it has wrestled with since 1986. In November, the agency's blood products advisory panel met with representatives from OraSure Technologies Inc. (Bethlehem, PA) to explore the company's OraQuick Advance Rapid HIV test as a potentially suitable candidate for at-home use.
Conor Medsystems Inc. (Menlo Park, CA) has received FDA approval to expand enrollment in the U.S. pivotal clinical trials of its Costar drug-eluting stent. In contrast to conventional surface-coated stents, Conor's stents incorporate hundreds of small holes, each acting as a reservoir into which drug-polymer compositions can be loaded.
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