In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for ...

Data sharing is critical to the validation of new biomarkers used in drug development, experts at the seventh annual Predictive Safety Testing Consortium (PSTC) workshop at the US Food and Drug ...

Drug development involves significant risk and expense. With average development costs topping $1 billion per approved medicine and stubbornly high failure rates, pharmaceutical leaders are ...