Ic. REGULATION AND REIMBURSEMENT OF MODERN MEDICINES

This Session considers the new and changing FDA environment for clinical trials that will potentially change development timelines, number of patients, and costs of trials. Also the Panel will consider key issues surrounding technology transfer and commercialization as trials move towards approval and the “do’s and don’ts” of manufacturing site selection related to FDA approval and provide insights into device development programs that would maximize the likelihood of early CMS reimbursement.