ARTICLE SUMMARY:
Our take on the impact of the Shuren era at FDA; Johnson & Johnson VP Paul Coplan discusses real-world evidence applications around the globe as well as J&J's pioneering efforts to obtain FDA-approved label extension using RWE; CDRH's Doug Kelly on the center's growing involvement in reimbursement matters; in Consultants' Corner, navigating the blurred lines between medical devices and software; and a new regulatory path for EU orphan devices.
