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Drug Industry Daily
Aug. 22, 2012 | Vol. 11 No. 165
Drug-Diagnostic Sponsors Must Educate Sites to Avoid Bias That Can Kill Approval
Sponsors of new drugs seeking approval with a companion in vitro diagnostic (IVD) need to work with trial sites to ensure they are not prescreening patients by local test methods — a process that can prove fatal for regulatory approval, an expert says.
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