FDA, CMS Discuss How To Share Real-World Data To Speed Drug Access

FDA, in its bid to tap real-world evidence to speed approvals of new drugs, is holding discussions with CMS to carve out each agency’s jurisdiction, FDA Principal Deputy Commissioner Amy Abernethy said. The two agencies have had a series of meetings to discuss how to promote and advance data-sharing, but there are still murky areas that need to be worked out, she added. “I think the other side of that is making sure that the American public understands whose responsibility...