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Home » Drug-Diagnostic Sponsors Must Educate Sites to Avoid Approval-Killing Bias
Drug-Diagnostic Sponsors Must Educate Sites to Avoid Approval-Killing Bias
August 29, 2012
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.