FDA requests proposals to strengthen real-world data methods supporting evidence generation and regulatory decisions

The FDA’s latest Broad Agency Announcement details two complementary streams of real-world data (RWD) methodology for evidence generation and regulatory decision-making, spanning cross-cutting research and disease- and product-specific areas including oncology, women’s health, rare diseases, drugs, biologics, and devices.

The US Food and Drug Administration (FDA) has published its 2026 regulatory science framework, setting out priority research areas of interest and highlighting how the agency aims to advance RWD and real-world evidence (RWE) methodologies across the medical product lifecycle. Issued through the agency’s Broad Agency Announcement (BAA), the framework provides a mechanism for the FDA to draw on the capabilities of industry, academia, and other research organizations to strengthen the scientific tools and methods that underpin regulatory decision-making.

The FDA has used the BAA mechanism since 2012 to solicit regulatory science research proposals. Under the 2026 BAA, the agency is inviting applications from industry, academic, and nonprofit organizations, with awards taking the form of research and development contracts of up to five years. The FDA will also host a Broad Agency Announcement Day on January 20, 2026, to outline its priorities and application process.

According to the agency, the regulatory science framework is built around three core “charges” central to the FDA’s mission:

• Modernizing the development and evaluation of FDA-regulated products
• Strengthening post-market surveillance and labeling
• Supporting public health preparedness and response

Within this framework, the 2026 priorities highlight two complementary methodological focus areas related to RWD: methods to assess RWD for RWE generation, and methods to assess RWD to support regulatory decision-making. These methods are applied across disease areas, product types, and patient populations as enabling capabilities within the broader regulatory science agenda.

Cross-cutting methods feature prominently across both methodological focus areas, with the FDA seeking proposals that advance approaches applicable across disease areas and product types. Priority areas include improving observational study design, strengthening causal inference, and addressing bias and confounding in real-world analyses, alongside methods to validate whether RWD are fit-for-purpose for RWE generation. The agency is also inviting proposals to develop standards for data quality and data sources that enhance the reliability, interoperability, and utility of RWD, as well as to strengthen data harmonization and evidence synthesis. Additional areas of interest include methodological research involving digital health technologies, patient-generated data, and the integration of RWD into clinical trial designs across both pre-market and post-market settings.

Oncology is identified as a priority domain across both methodological focus areas. For RWE generation, the FDA is seeking methods to support the use of registries, development and validation of real-world endpoints, and AI-enabled approaches to analyze oncology RWD. Under regulatory decision-making, priorities include methodological approaches to post-market safety monitoring and evaluation of serious toxicities observed in routine clinical practice.

Women’s health priorities focus on methodologies that use RWD to assess safety, effectiveness, and clinically relevant sex differences. The FDA highlights interest in scalable data mining and analytical approaches to identify women’s health issues across large datasets, as well as methods to support post-market assessments using both US and international RWD sources.

Rare diseases are addressed through an emphasis on methods that leverage RWD sources, including patient registries, to support evidence generation in small and heterogeneous populations. The FDA is seeking approaches that can inform screening strategies, evaluate therapeutic effects, and support regulatory assessments where conventional clinical trials may be limited by feasibility or sample size.

Drugs, biologics, and devices span product-specific methodological priorities under the BAA. For drugs, the FDA highlights methods to design, conduct, and analyze externally controlled trials using RWD, with particular attention to bias, confounding, and endpoint validity. In biologics, priorities include methodological approaches to replicate findings from randomized controlled trials using RWD, alongside efforts to develop standards for data quality and data sources that improve the interoperability and utility of RWD. For medical devices, the agency is seeking methods to monitor the real-world performance of AI-enabled technologies, as well as approaches to post-market surveillance and risk communication.

Beyond RWD methodologies, the 2026 BAA also encompasses a broader range of regulatory science priorities aligned with the FDA’s three core charges. These include novel clinical trial designs, biomarkers, predictive toxicology, and approaches to incorporate patient input to modernize product development; automated safety reporting, active surveillance, risk communication, and artificial intelligence to strengthen post-market oversight; and medical countermeasures, antimicrobial resistance, global product safety, substance use and misuse, and emerging technologies to support public health preparedness.

Applications under the 2026 BAA are open until February 24, 2026.