FDA’s Breakthrough Therapy DesignationByChristopher-Paul MilneSeptember 8th 2015Three key questions dominate the agency’s Breakthrough Therapy Designation program since its 2012 launch.
Meeting Unmet Medical Needs: The Disparity DilemmaByKenneth I Kaitin,Christopher-Paul MilneFebruary 1st 2015The US drug regulatory system fails to address the country’s most urgent medical needs with the resources appropriate for the task. But change is possible.