Bipartisan Policy Center Urges FDA Guide On Real-World Data, Central IRBs

The Bipartisan Policy Center recommended ways to leverage real-world evidence to modernize the drug development process, calling for FDA guidance on use of real-world evidence, greater sharing of best practices and an FDA program to develop and test a new adaptive pathway approach. The suggestions were produced by BPC's FDA: Advancing Medical Innovation initiative, which is chaired by former Tennessee Sen. William Frist (R) and former Rep. Bart Gordon (D). "Integrating real-world evidence into today's drug development process will require...