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Regulatory Focus™ > News Articles > 2019 > 2 > FDA Offers Glimpse Into New Guidance Under RWE Framework

FDA Offers Glimpse Into New Guidance Under RWE Framework

Posted 05 February 2019 | By Ana Mulero 

FDA Offers Glimpse Into New Guidance Under RWE Framework

A top US Food and Drug Administration (FDA) official offered a glimpse into upcoming FDA guidances under the agency’s new real-world evidence (RWE) framework for regulatory decision-making.

The agency unveiled its RWE framework last December to provide a high-level view of how it is looking at the use of real-world data, Sean Khozin, acting associate director of oncology, regulatory science and informatics at FDA’s Oncology Center of Excellence noted Monday during a session at the National Health Policy Conference in Washington, DC. The session focused on the future RWE policy directions.  

With the release of the RWE framework, FDA indicated that more guidance will be developed and issued to expand on the agency’s RWE program.

“There is an emerging opportunity to capture data from other sources that reflect the patient’s experience and individuals’ experience,” Khozin argued. “This could be anything from telemedicine consults that are conducted as part of the routine delivery of care and digital health tools.”

Under the RWE framework, an upcoming guidance document will specifically address the use of data from electronic health records. Another guidance document on mobile technology is currently under development as well. Yet another will look at the use of registries. Further, Khozin noted that FDA is also considering guidance on the prospective examination of real-world data sources.

“We’re thinking about providing guidance on how to potentially use these data sources for prospective examination where randomization will also be feasible,” Khozin said. This would seek to encourage the use of RWE to support findings of medical product effectiveness.


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