Zhaohui Su, the Vice President of Biostatistics at Ontada, shared a post on LinkedIn:
“The FDA has removed a major barrier to using real-world evidence (RWE) in drug and device application reviews. New guidance allows sponsors to submit RWE without including identifiable patient-level data, making large de-identified databases eligible for regulatory consideration. This change addresses previous limitations that restricted RWE use despite its potential to inform treatment effectiveness. Historically, FDA required confidential individual data.
The updated policy enables broader use of sources, accelerating approvals and supporting evidence-based decisions. FDA will assess RWE strength case by case, promoting faster patient access to innovative therapies.
Source.
Thanks to Doro Shin, MPH for sharing this exciting news.”
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Zhaohui Su: Embracing Real-World Data to Power Rare Cancer Research
