Managing Principal Maral DerSarkissian and Affiliate Mark S. Robbins Join FDA Watch Podcast to Discuss the Role of Real-World Evidence in Accelerated Approvals

October 21, 2026

Delivering promising drugs to patients in a timely manner without sacrificing scientific rigor is at the center of the US Food and Drug Administration's (FDA's) approach to accelerated approval. As the agency seeks to balance faster patient access with more rigorous evidentiary standards and greater post-market accountability, sponsors and investors increasingly rely on real-world evidence (RWE) as part of their regulatory strategy.

Analysis Group Managing Principal Maral DerSarkissian and affiliate Mark S. Robbins participated in the third installment of the FDA Watch podcast’s series on the use of RWE in regulatory contexts. Joined by Bethany Hills (Partner, White & Case), their conversation began with an overview of expedited FDA drug development and review pathways and the foundations of the accelerated approval pathway, specifically. The discussion ranged from where RWE fits into the evidence strategy for accelerated approvals to notable recent developments that could lead to practical changes for pharmaceutical companies and investors. Topics included the value of accelerated approval to sponsors and investors and expanded oversight authority granted to the FDA under the Food and Drug Omnibus Reform Act (FDORA). The participants also discussed how RWE can strengthen an application package, highlighted the importance of engaging the FDA early in the review process, outlined limitations and controversies surrounding RWE, and addressed legal and compliance considerations for sponsors.

They described FDA reviewers as receptive to RWE but demanding, taking that type of evidence most seriously when it is planned proactively. They highlighted FDA’s expectations for RWE, including development of a rigorous protocol, the importance of demonstrating that a data source is fit-for-use, and sensitivity analyses as key to demonstrating robustness of results. They also noted that RWE may be used to validate surrogate endpoints, build external control arms, and contextualize natural history, and that for vaccines, pragmatic trials using real-world data can help convert an accelerated approval to full approval.

Analysis Group is proud to sponsor FDA Watch’s “The Rise of Real-World Evidence in Regulatory Strategy” series.    

Learn more about Part III: Real-World Evidence in Accelerated Approvals here, or listen on Spotify or Apple Podcasts

Listen to other episodes in the series:
Part I: Real-World Evidence in Rare Disease Drug Development
Part II: Real-World Evidence in Medical Devices