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Blood Safety

FDA still lacks timetable for tissue bank oversight

Published in Blood Weekly, June 5th, 2003

The U.S. Food and Drug Administration (FDA) says it has no timetable for long-delayed regulations governing hundreds of tissue banks despite at least one death from infected tissue and evidence of widespread problems.

The chairwoman of a Senate oversight panel demanded that the FDA issue the regulations, as did Steve and Leslie Lykins, whose 23-year-old son died in 2001 after receiving infected bone during knee reconstruction surgery.

"This industry has been allowed to operate like something out of the wild West for too long," Steve Lykins of Willmar, Minnesota, told the Senate Government Affairs Committee. "We just don't understand why this is...

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