Experts: Collaboration Needed To Advance FDA RWE Framework

FDA’s framework for real-world evidence, released Dec. 6, illustrates the agency’s commitment to working with outside groups to expand the use of RWE and real-world data (RWD) in drug approvals and labeling, experts say. But one lawyer notes the framework is only a workplan, leaving stakeholders to wait and see how FDA implements the potential policies it has laid out, including the possible use of observational trials and use of RWE to support labeling changes. FDA earlier this month released...