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Home » IRB Warned for Failure to Ensure Patient Safety, Document Actions
IRB Warned for Failure to Ensure Patient Safety, Document Actions
December 8, 2009
The Burzynski Research Institute’s institutional review board (IRB) failed to discuss a board member’s concerns about the source of an investigational
drug for a safety and efficacy study, its manufacturing process and the need for a patient risk-benefit analysis, an FDA warning letter says.
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