FDA Developing Guidance On Real-World Data Quality Issues, Officials Say

Sep 11, 2019, 10:20 by Michael Croft

Endpoints News | As the FDA grapples with how to use real-world data for regulatory decisions, two FDA officials wrote in a perspective published last Friday in the Clinical Journal of the American Society of Nephrology that the agency is developing guidance on data quality issues unique to the real-world data setting and related study design considerations.

September 11, 2019 | As the FDA grapples with how to use real-world data for regulatory decisions, two FDA officials wrote in a perspective published last Friday in the Clinical Journal of the American Society of Nephrology that the agency is developing guidance on data quality issues unique to the real-world data setting and related study design considerations. Endpoints News