Zhaohui Su, VP of Biostatistics at Ontada, shared a post on LinkedIn by The Evidence Base, adding:
“This post highlights two key priorities in the FDA’s 2026 regulatory science framework: methods to assess RWD for RWE generation and methods to assess RWD to support regulatory decision-making.
Focus areas include oncology, women’s health, rare diseases, and product-specific domains. Goals center on improving study design, causal inference, bias mitigation, and data quality standards. Applications are due February 24, 2026; FDA will host BAA Day on January 20, 2026.”
Quoting The Evidence Base’s post:
“The FDA has published its 2026 regulatory science framework, setting out priorities for advancing RealWorldData and RealWorldEvidence methods across the medical product lifecycle. Issued through the Broad Agency Announcement, the framework highlights two complementary methodological tracks focused on RWE generation and regulatory decision-making.
Read here.”
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