Use of Real-World Evidence in Post-Marketing Commitment Studies Explored by Managing Principal Marianne Cunnington on FDA Watch Podcast

November 4, 2026

Approaches to post-marketing monitoring of new product safety and effectiveness have evolved over recent decades with real-world evidence (RWE) playing an increasing role in fulfilling post-marketing commitments for the US Food and Drug Administration (FDA). In an installment of the FDA Watch podcast’s series on RWE in regulatory contexts, Analysis Group Managing Principal Marianne Cunnington, who specializes in RWE for risk management, joined Robert Reynolds (GlaxoSmithKline) to discuss how RWE supports these commitments and how evolving evidentiary standards could strengthen the value of RWE for patients and prescribers.

Participants explored the evolution of post-marketing studies, including the triggers for FDA-mandated studies and the questions that can only be answered in real-world settings.  The conversation covered standards to support regulatory expectations for robust evidence generation, alongside opportunities for emerging technologies to improve the scope, quality, and efficiency of post-marketing research. Participants also considered the new draft guidance by FDA that discusses approvals based on a single pivotal trial supported by confirmatory evidence; this change may further increase the need for robust pre-approval and post marketing RWE. The participants emphasized the value of early evidence-generation planning and engagement with FDA to help sponsors balance accelerated development timelines with post-marketing obligations.

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

Learn more about Part IV: Real-World Evidence in Post-Marketing Commitments, 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
Part III: Real-World Evidence in Accelerated Approvals