FDA Details How Drug, Biologic Sponsors Can Use RWE In Applications

FDA issued draft guidance explaining how drug and biologic sponsors can document their use of real-world evidence in drug and biologics applications, in a bid to encourage industry use of such evidence to seek product approvals or labeling changes. Identifying the use of such data in a simple, uniform format will also help the agency track use of real-world evidence in regulatory submissions, the draft guide says. FDA plans to host a webinar on the draft guidance in mid-to-late May...