A recent article by Cato Research Postdoctoral Research Fellow Dieanira Erudaitius offers a brief summary on the Food and Drug Administration’s real-world evidence initiative.
The agency’s program, she writes, would look to allow RWE in the review process of new indications and to support post-approval study requirements.
“The new RWE program will be implemented through the utilization of a multifaceted framework,” she writes. “The framework outlines a number of guidance documents, their plans to engage experts across specialties and fields, and various assessments to produce acceptable standards for developers … .”
