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FDA outlines Advancing RWE pathway, reviews guidance and submission pitfalls

FDA Grand Rounds — Office of Medical Policy, Center for Drug Evaluation and Research · February 5, 2026

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Summary

At an FDA Grand Rounds, Dr. Marie Bradley described the Advancing Real World Evidence pathway (launched under PDUFA VII), guidance development, common reasons RWE submissions fail, and operational advice for sponsors seeking early consultation.

At FDA Grand Rounds, Dr. Marie Bradley described the agency’s Advancing Real World Evidence pathway and key messages for sponsors considering RWD in regulatory submissions.

Bradley said the Advancing RWE pathway — launched as a PDUFA VII commitment in 2023 — is an optional early consultation process that allows sponsors up to four meetings with FDA. She noted semiannual submission windows and reported that six cycles have yielded 29 requests; six were accepted (three completed, three ongoing) and 23 were denied.

She emphasized four program pillars from the 2018 FDA framework: internal agency processes, external stakeholder engagement, demonstration projects and guidance development. Bradley urged sponsors to engage early with FDA, preregister study protocols, make patient‑level data available for reanalysis and ensure traceability of data sources.

Common pitfalls and guidance

Bradley identified common reasons RWE submissions fail: incomplete capture of required study elements (for example missing lab values), lack of traceability to source data partners, inappropriate comparator selection in externally controlled trials, and failure to prespecify analyses. She said FDA is working on policy and technical solutions for data standards and data‑format mapping to reduce conversion errors.

Bradley pointed to multiple center guidances (CDER, CBER, OCE and CDRH) and said several guidance documents are in draft and under revision based on external comments. She repeated that the statutory standard for substantial evidence has not changed and that RWE can support regulatory decisions when data and design are fit for purpose.

Practical advice and next steps

Bradley recommended sponsors consult with FDA early and often, use listening sessions to discuss novel data sources or methods, and consider demonstration projects or the Advancing RWE pathway for complex proposals. She concluded by providing the CDER RWE mailbox for follow‑up and encouraged participation in public meetings.