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March 8, 2007
By: Ed Kensik
NULL
BSD Medical Corp said it received a warning letter from FDA relating to concerns about clinical study conduct errors at an investigational site, according to Reuters News Service. The warning letter addresses three general areas — monitoring, securing investigator compliance with the protocol and reporting, the company said in a statement. The Salt Lake City, UT-based company is a manufacturer of systems used to deliver precision-focused thermal treatments for cancer. The company said research data from this site, closed to treating patients since Aug. 31, has not been used to seek regulatory approval for any product or to statistically support the efficacy of BSD systems in treating patients. The letter has nothing to do with the safety, efficacy, quality, design or manufacture of its equipment, it added. BSD said it plans to provide the FDA with a full report of its efforts to address the agency’s concerns.
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