May 31, 2017
Dr. Gottlieb’s Remarks to the 2017 FDA Science Forum feature the MDIC Virtual Patient work: “… CDRH, in collaboration with members of academia and the device industry, are developing novel methods to create models of virtual patient outcomes. Leveraging prior clinical data, these models can be used to augment and, thereby, reduce the time and cost of future clinical trials. It can also improve efficiency. FDA, through CDRH, is now using this approach in a mock premarket submission review.
