Date: October 13, 2026
Journal: Health Affairs Forefront
Citation: Neumann PJ, Hatfield GM, Lin P, Manandhar T, Tunis S. Can Real-World Evidence Reliably Fill Evidence Gaps In Accelerated Approval? Health Affairs Forefront. October 13, 2026.
Four years after the Food and Drug Omnibus Reform Act (FDORA) strengthened the Food and Drug Administration’s (FDA’s) accelerated approval pathway, questions persist about the best way to generate evidence in the post-approval period. A key area pertains to the role of real-world evidence (RWE), which the FDA defines as “clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD” (real-world data). As the availability of post-market RWE expands, more attention to its promise, limitations, and oversight in the context of accelerated approval is needed.
